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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Adcomm

Meeting Date: 6/25/14-6/25/14

Meeting Details:

he committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 11/4/13-11/5/13

Meeting Details:

The recent permanent reauthorization of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) and their associated amendments require earlier consideration of pediatric study plans. The need for suitable outcome assessment tools to evaluate treatment benefit of new cancer drugs on how a patient feels and/or functions as well as survives necessitates consideration of the potential challenges to the use of patient reported outcomes (PROs) in the pediatric age group. The 2009 “FDA Guidance for Industry: Patient-Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims” does not specifically address the relevance and potential use of such measures in the pediatric development plans of oncology products. The half-day session will provide an opportunity to review the Agency’s position on the use of PROs in the pediatric population in general. As well, participants will review the current state of the science of the evaluation of pertinent health-related quality of life measures in children with cancer across the various age and developmental subgroups of children. Participants will discuss potential contexts of use for measuring both observable and unobservable concepts in specific pediatric cancer diagnoses across relevant age groups and defined disease stages using validated tools. No specific drug or biologic products or class of products will be discussed. During the morning session, there will be a presentation and general discussion of the potential applicability of pharmacological and cellular manipulation of the immune system, as a potential therapeutic intervention in various pediatric cancers. The recent, dramatic results of inhibition of the PD-1/PD-L1 axis and checkpoint inhibitors on normal T cells in melanoma and other adult cancers strongly suggest a potential role for such agents in the management of childhood cancer. Information will be presented regarding pediatric development plans for two products that are in late stage development for various adult oncology indications. The subcommittee will consider and discuss issues relating to the development of each product for potential pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The two products under consideration are: (1) nivolumab, application submitted by Bristol Myers Squibb Co.; and (2) MK-3475, application submitted by Merck Sharp and Dohme. During the afternoon session, information will be presented regarding pediatric development plans for LEE011, application submitted by Novartis Pharmaceuticals Corporation, a product in early-stage development for adult and pediatric oncology indications. The subcommittee will consider and discuss issues relating to the development of this product for possible pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 9/12/13-9/12/13

Meeting Details:

On September 12, 2013, the committee will discuss supplemental biologics license application 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (tumor greater than 2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin, and cyclophosphamide or carboplatin.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Medical Imaging and the Oncologic Drugs AdComm

Meeting Date: 5/3/13-5/3/13

Meeting Details:

On May 3, 3013, the committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE, (sargramostim, Genzyme, Inc.), and 125294, TBO–FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 5/2/13-5/2/13

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic Drugs AdComm

Meeting Date: 12/4/12-12/4/12

Meeting Details:

The subcommittee will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. This will be an awareness presentation and there will not be a formal Committee discussion or recommendation. In addition, information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/25/12-7/25/12

Meeting Details:

The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/24/12-7/24/12

Meeting Details:

During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s). During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 9:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 6/20/12-6/20/12

Meeting Details:

On June 20, 2012, during the morning session, the committee will discuss new drug application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score = 3. During the afternoon session, the committee will discuss NDA 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 3/20/12-3/21/12

Meeting Details:

On March 20, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 022465/S-010, VOTRIENT (pazopanib hydrochloride) Tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd. doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors. During the afternoon session, the committee will discuss NDA 022576, with the proposed trade name TALTORVIC (ridaforolimus) Tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression. On March 21, the committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 2/8/12-2/9/12

Meeting Details:

The committee will discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML. During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/7/11-12/7/11

Meeting Details:

On December 7, 2011, during the morning session, the committee will discuss new drug application (NDA) 202324, with the proposed trade name Inlyta (axitinib) tablets, application submitted by Pfizer, Inc. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma (kidney cancer).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 9/14/11-9/14/11

Meeting Details:

On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) film-coated tablets, application submitted by ApoPharma, Inc., represented by Cato Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsSeattle Genetics - Oncologic Drugs AdComm

Meeting Date: 7/14/11-7/14/11

Meeting Details:

During the morning session, the committee will discuss Biologics License Application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma (HL). During the afternoon session, the committee will discuss Biologics License Application (BLA) 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 4/12/11-4/12/11

Meeting Details:

On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S-009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung, or pancreatic origin. During the afternoon session, the committee will discuss sNDA 021938/S-013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm - CANCELLED AGAIN !!!

Meeting Date: 2/9/11-2/9/11

Meeting Details:

CANCELLED FOREVER - On February 9, 2011, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers Squibb Co.. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 2/8/11-2/8/11

Meeting Details:

Agenda: The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are postmarketing studies to confirm clinical benefit of a drug after it receives accelerated approval. Specifically, the committee will receive updates on the following products: (1) BLA 125084, trade name ERBITUX (cetuximab), application submitted by Imclone Systems Inc., used in combination with the anticancer agent irinotecan and indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing colorectal cancer that has metastasized (spread beyond the colon or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective; (2) supplemental BLA (sBLA) 125011/24, trade name BEXXAR (tositumomab and Iodine I 131 tositumomab), application submitted by SmithKline Beecham Corp. doing business as (d/b/a) GlaxoSmithKline, indicated for the treatment of patients with varieties of non-Hodgkin’s lymphoma known as CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, who have not received the drug 3 Rituximab; (3) NDA 21-673, tradename CLOLAR (clofarabine) for intravenous infusion, application submitted by Genzyme Corp., indicated for the treatment of pediatric patients 1 to 21 years old with acute lymphoblastic leukemia (ALL) whose disease has not responded to or has relapsed following treatment with at least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or lymphoma known as T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens; (5) BLA 125147, tradename VECTIBIX (panitumumab), application submitted by Amgen Inc., indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens; and (6) sNDA 21-588/025, tradename GLEEVEC (imatinib mesylate) tablets, application submitted by Novartis Pharmaceuticals Corp., indicated for the adjuvant (additional) treatment of adult patients following complete gross resection (removal) of a form of cancer known as Kit (CD117) positive gastrointestinal stromal tumors (GIST). Based on the updates provided, the committee will have a general discussion centering on possible ways to improve the planning and conduct of trials to confirm clinical benefit (post marketing requirements). The overall goal will be the optimization of the accelerated approval process with a focus on decreasing the amount of time to confirm (or fail to confirm) clinical benefit while continuing to provide early availability of promising oncology products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 12/1/10-12/2/10

Meeting Details:

On December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules, manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride) Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposed expansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined. On December 2, 2010, during the morning session, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee will discuss new drug application (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/20/10-7/20/10

Meeting Details:

On July 20, 2010 the committee will discuss supplemental biologics license applications (sBLAs) 125085/191 and 192 for AVASTIN (bevacizumab), manufactured by Genentech, Inc. The two proposed indications (uses) for this product are: (1) first-line treatment of a subgroup of women with metastatic breast cancer known as HER2-negative breast cancer, in combination with the chemotherapy drug docetaxel; and (2) first-line treatment of HER2-negative metastatic breast cancer in combination with one of two classes of chemotherapy drugs, known as taxanes and anthracyclines, or with the chemotherapy drug, capecitabine. In addition to the discussion of these two indications, the committee will also consider the impact of the submitted studies on the conversion from accelerated to regular approval of the indication for the treatment, in combination with the chemotherapy drug paclitaxel, of patients who have not received chemotherapy for their locally recurrent or metastatic HER2 negative breast cancer.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNew Date - Oncologic Drugs AdComm

Meeting Date: 3/22/10-3/22/10

Meeting Details:

On March 22, 2010, during the morning session, the committee will discuss new drug application (NDA) 022481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin's lymphoma (NHL) who have received two or more prior lines of therapy. During the afternoon session, the committee will discuss NDA 022374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug IMATINIB.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNew Time: Starts at 9AM EST = Oncologic Drugs AdComm

Meeting Date: 12/16/09-12/17/09

Meeting Details:

On December 16, 2009, during the morning session, the committee will discuss supplemental new drug application (sNDA) 021743/S016, TARCEVA (erlotinib) tablets, by OSI Pharmaceuticals, Inc. The proposed indication (use) for this product is first-line maintenance, monotherapy (first-choice, single drug) treatment in patients with a form of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (has spread regionally within the lung and/or within chest lymph nodes) or metastatic (has spread beyond the lung), and who have not progressed (including those patients with stable disease) on first-line treatment with platinum-based chemotherapy (a regimen including a platinum drug (cisplatin or carboplatin) plus another chemotherapy drug). During the afternoon session, the committee will discuss supplemental new drug application (sNDA) 022059/S007, TYKERB (lapatinib) tablets, by SmithKline Beecham Ltd. doing business as GlaxoSmithKline. The proposed indication (use) for this product is in combination with an aromatase inhibitor for the treatment of hormone sensitive advanced or metastatic breast cancer. On December 17, 2009, the committee will discuss new drug application (NDA) 022555, proposed trade name HEXVIX (hexaminolevulinate as hydrochloride) Kit, for the preparation of HEXVIX solution for intravesical use, by Photocure ASA. The product is a diagnostic imaging agent that becomes visible when illuminated by blue light, a special type of light that causes the agent to appear a certain (fluorescent) color. The agent is proposed for administration into the bladder to help in the examination of the bladder wall with a cystoscope, a surgical instrument used to detect some types of cancer. The proposed indication (use) for this product is for blue light cystoscopy performed with the Karl Storz Photodynamic Diagnosis (PDD) system (equipment that produces blue light) as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 12/15/09-12/15/09

Meeting Details:

The subcommittee will consider and discuss: (1) FDA expectations regarding the development of pediatric formulations for cancer drugs, and (2) the development of dosing regimens in infants and toddlers with cancer.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 10/5/09-10/5/09

Meeting Details:

On October 5th, the committee will discuss: (1) Supplemental biologics license application (sBLA) 103949/5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by Schering Corp. The proposed indication (use) for this product is as an adjuvant (additional) treatment for melanoma, a kind of skin cancer. The primary treatment for melanoma that is metastatic (has spread) to the lymph nodes is surgery to remove both the original cancer and lymph nodes surrounding the cancer. PEGINTRON's proposed use is as a treatment in addition to, or as an adjuvant, to surgery. (2) New drug application (NDA) 022465, proposed trade name VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer. DAY 2 CANCELLED...

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/2/09-9/2/09

Meeting Details:

The committee will discuss: (1) new drug application (NDA) 022393, with the proposed trade name ISTODAX (romidepsin) Injection, manufactured by Gloucester Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of cutaneous T-cell lymphoma (CTCL), a form of cancer that arises in cells located in the skin, including relief of pruritus (itching), in patients who have received at least one prior systemic therapy; and (2) NDA 022468, with the proposed trade name FOLOTYN (pralatrexate) Injection, manufactured by Allos Therapeutics, Inc., with a proposed indication for the treatment of patients with relapsed or refractory (recurring and/or not responsive to other treatments) peripheral T-cell lymphoma (PTCL), a form of cancer that develops from cells in the body known as T-cells.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/1/09-9/1/09

Meeting Details:

The committee will discuss the following topics: (1) Supplemental new drug application (sNDA) 021673/S009, CLOLAR (clofarabine) Injection for intravenous use, Genzyme Corp., proposed indication for the treatment of previously untreated adults aged 60 years or older with acute myeloid leukemia with at least one unfavorable baseline prognostic factor and (2) new drug application (NDA) 022489, proposed trade name ONRIGIN (laromustine) Injection, Vion Pharmaceuticals, Inc., proposed indication for remission induction therapy for patients 60 years or older with de novo poor-risk acute myeloid leukemia (AML).

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/15/09-7/15/09

Meeting Details:

The committee will discuss: (1) new drug application (NDA) 022447, proposed trade name YONDELIS (trabectedin) powder, for concentrate for solution for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with DOXIL (doxorubicin HCl liposome injection), for the treatment of patients with relapsed ovarian cancer; and (2) supplemental new drug application (sNDA) 050718/S039, DOXIL (doxorubicin HCl liposome injection), for intravenous infusion, Centocor Ortho Biotech Products, L.P., proposed indication in combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer who have received prior anthracycline treatment.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 5/29/09-5/29/09

Meeting Details:

On May 29, 2009, the committee will discuss the biologics license application (BLA) 125326, proposed trade name Arzerra (ofatumumab), GlaxoSmithKline, for the proposed indication of treatment of patients with chronic lymphocytic leukemia who have received prior therapy.

 

       
Location: Rosen Shingle Creek Panzacola Ballroom 9939 Universal Boulevard Orlando, FL 32819 Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/31/09-3/31/09

Meeting Details:

The committee will discuss supplemental biologics license application (sBLA) 125085/169, AVASTIN (bevacizumab), Genentech, Inc., proposed indication as single agent for the treatment of previously treated glioblastoma multiforme.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/16/08-12/16/08

Meeting Details:

The committee will discuss biologics license application (BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc., and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development.

 

       
Location: Hilton Washington DC North/Gaithersburg The Ballrooms 620 Perry Parkway Gaithersburg, MD 20877 Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 5/30/08-5/30/08

Meeting Details:

The committee will discuss the new drug application (NDA) 022-291, proposed trade name PROMACTA (eltrombopag olamine), by GlaxoSmithKline, proposed indication for the short-term treatment of previously-treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.

 

       
Location: Chicago IL Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 4/16/08-4/16/06

Meeting Details:

The subcommittee will consider and discuss opportunities for enhancing global pediatric oncology drug development and expanding international regulatory interactions given the January 2007 legislation introduced in the European Union that governs the development and authorization of medicines for use in children aged 0 to 17 years.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/12/08-3/13/08

Meeting Details:

On March 12, 2008, the committee will discuss: (1) Biologic license application (BLA) 125268, proposed trade name NPLATE (romiplostim), Amgen Inc., proposed indication for the treatment of thrombocytopenia in adults with chronic immune (idiopathic) thrombocytopenia purpura who are nonspelenectomized and have had an inadequate response or are intolerant-to corticosteroids and/or immunoglobulins; or patients who are splenectomized and have an inadequate response to splenectomy, and (2) supplemental biologics license application (sBLA) 103949/5 15 3, PEGINTRON (peginterferon alfa-Zb), Schering Corp., proposed indication for adjuvant treatment of melanoma. On March 13, 2008, the committee will discuss the cumulative data, including recent study results, on the risks of erythropoeisis-stimulating agents when administered to patients with cancer. Agents to be discussed include ARANESP (darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa, Amgen, Inc.), and MIRCERA (methoxy polyethylene glycol-epoetin beta, Hoffman-La Roche Inc.). This is a followup to the May 10, 2007, Oncologic Drugs Advisory Committee Meeting.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/5/07-12/5/07

Meeting Details:

On December 5, 2007, from 8 a.m. to 3 p.m., the committee will discuss supplemental biologics license application (sBLA) 125085/91, AVASTIN (bevacizumab), Genentech, Inc., proposed indication, in combination with paclitaxel, for the treatment of patients who have not received chemotherapy for their locally recurrent or metastatic, HER2 negative breast cancer.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 7/24/07-7/24/07

Meeting Details:

The committee will discuss the following new drug applications (NDAs): (1) NDA 022–042, EVISTA (raloxifene hydrochloride) Tablets, Eli Lilly and Co., proposed indications for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of breast cancer; and (2) NDA 021–801, proposed trade name ORPLATNA (satraplatin capsules), GPC Biotech Inc., proposed indication for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) that has failed prior chemotherapy.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/9/07-5/10/07

Meeting Details:

On May 9, 2007, the committee will do the following: (1)Discuss new drug application (NDA) 022-092, proposed trade name JUNOVAN (mifarnurtide), IDM Pharma, Inc., proposed indication for the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy; and (2) discuss NDA 022-062, proposed trade name ORBEC (beclomethasone dipropionate), DOR BioPharma, Inc., proposed indication for the treatment of graft versus host disease (GvHD) involving the gastrointestinal tract in conjunction with an induction course of high-dose prednisone or prednisolone. On May 10, 2007, the committee will discuss updated information on risks of erythropoeisis stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) for use in the treatment of anemia due to cancer chemotherapy.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/6/06-9/7/06

Meeting Details:

On September 6, 2006, the committee will discuss two new drug applications (NDAs): (1) NDA 21-874, proposed trade name GENASENSE (oblimersen sodium) Injection, Genta, Inc., proposed indication for the treatment of patients with chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide; and (2) NDA 020-287, FRAGMIN (dalteparin sodium), Pfizer, Inc., proposed indication for the extended treatment of symptomatic venous thromboembolism (VTE), proximal deep vein thrombosis, and/or pulmonary embolism to reduce the recurrence of VTE in patients with cancer. On September 7, 2006, the committee will discuss NDA 21-660, ABRAXANNE (paclitaxel protein-bound particles for injectible suspension) (albumin-bound), Abraxis Bioscience, Inc., including trial design issues for adjuvant treatment of node-positive breast cancer.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 6/2/06-6/2/06

Meeting Details:

The committee will discuss new drug application (NDA) 21-986, proposed trade name SPRYCEL (dasatinib) tablets, Bristol-Myers Squibb Co., with proposed indications for the: (1) Treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib and (2) treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia, and lymphoid blast chronic myeloid leukemia with resistance or intolerance to prior therapy.

 

       
Location: Atlanta, Georgia Related News Links: Not Available
Time: 10:00AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/13/06-3/13/06

Meeting Details:

The committee will discuss the following: (1) Receive and discuss pediatric update from the October 20, 2005, meeting of the Pediatric Oncology Subcommittee; (2) discuss pre-clinical requirements and phase 1 trial design issues for the development of oncologic products; and (3) discuss new drug application (NDA) 20-509, S-039, GEMZAR (gemcitabine hydrochloride) for Injection, Eli Lilly & Co., proposed indication for use in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/8/05-11/8/05

Meeting Details:

The committee will discuss new drug applications approved under 21 CFR 314.500 and 601.40 (Subparts H and Subpart E, respectively, accelerated approval regulations) in an open session to do the following: (1) Review the status of phase IV clinical studies; (2) identify difficulties associated with completion of phase IV commitments; and (3) provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs. The committee will discuss phase IV commitments of: (1) new drug application (NDA) 50-718, DOXIL (doxorubicin hydrochloride liposome injection, Johnson and Johnson Pharmaceutical Research and Development, L.L.C.) for the treatment of acquired immune deficiency syndrome (AIDS) related Kaposi's sarcoma in patients with disease that has progressed on prior combination therapy or in patients who are intolerant to such therapy; (2) NDA 20-221/S-002, ETHYOL for injection (amifostine, MedImmune Oncology, Inc.) for reducing the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced non-small cell lung cancer; (3) biologics license application (BLA) 103767/0, ONTAK (denileukin diftitox, Seragen Incorporated) for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor; (4) NDA 21-041, DEPOCYT (cytarabine liposome injection, SkyePharma Inc.) for the intrathecal treatment of lymphomatous meningitis; and (5) NDA 21-156, CELEBREX (celecoxib capsules, Pfizer Inc.) for reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis, as an adjunct to usual care (e.g., endoscopic surveillance, surgery); (6) NDA 21-174, MYLOTARG (gemtuzumab ozogamicin for injection, Wyeth Pharmaceuticals, Inc.) for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy; and (7) BLA 103948/0, CAMPATH (alemtuzumab, ILEX Pharmaceuticals, L.P.) for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic AdComm

Meeting Date: 10/20/05-10/20/05

Meeting Details:

The subcommittee will do the following: (1) present the structure and function of the Office of Oncology Drug Products in CDER, (2) discuss issues involved with the conduct of certain pediatric post-marketing studies for products approved for oncologic indications, 3) review status of studies for specific off-patent drugs for pediatric oncology, and 4) consider other off-patent oncology drugs for which pediatric studies are needed, as mandated by the Best Pharmaceuticals for Children Act.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 9/13/05-9/14/05

Meeting Details:

On September 13, 2005, the committee will discuss the following: (1) new drug application (NDA) 21-491, proposed trade name XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories, proposed indication for the treatment of men with metastatic hormone-refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA (erlotinib) TABLETS, OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metastatic pancreatic cancer. On September 14, 2005, the committee will discuss the following: (1) NDA 21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp., proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; and (2) NDA 21-877, proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline, proposed indication for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, at least two chemotherapy regimens.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 5/5/05-5/5/05

Meeting Details:

The committee will discuss new drug application (NDA) 21-824, proposed trade name ZARNESTRA (tipifarnib) Film Coated Tablets, Tibotec Therapeutics, a Division of Ortho Biotech, L.P., proposed indication for the treatment of elderly patients with newly diagnosed poor-risk acute myeloid leukemia.

 

       
Location: FDA - Rockville Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/3/05-3/4/05

Meeting Details:

On March 3, 2005, the committee will do the following: (1) Discuss new drug application (NDA) 21-115, COMBIDEX (ferumoxtran-10), Advanced Magnetics, Inc., proposed indication for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases, and (2) discuss prostate cancer endpoints as a follow up to the June 2004 FDA workshop. On March 4, 2005, the committee will do the following: (1) Discuss the results of a confirmatory trial for NDA 21-399, IRESSA (gefitinib) AstraZeneca Pharmaceuticals LP, for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, and (2) discuss safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21-223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp. ZOMETA is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. It is also approved for hypercalcemia of malignancy. AREDIA is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. It is also indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, and treatment of patients with moderate to severe Paget's disease of bone.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic AdComm

Meeting Date: 12/1/04-12/1/04

Meeting Details:

The committee will discuss these items: (1) New Drug Application (NDA) 21-673, proposed trade name CLOLAR (clofarabine) Ilex Products, Inc., proposed indication for the treatment of pediatric patients 1 to 21 years old with refractory or relapsed acute leukemias, and (2) NDA 21-600, proposed trade name MARQIBO (vincristine sulfate liposome injection) Inex Pharmaceuticals Corp., proposed indication for the treatment of patients with aggressive non-Hodgkin's lymphoma previously treated with at least two combination chemotherapy regimens.

 

       
Location: FDA Rockville Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/27/04-7/27/04

Meeting Details:

The committee will discuss new drug application (NDA) 21-677, ALIMTA (pemetrexed) Eli Lilly, Inc., proposed indication for single-agent treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after prior chemotherapy.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 5/3/04-5/4/04

Meeting Details:

On May 3, the committee will discuss 1) NDA Genasense Genta Inc. proposed indication for use in combination with DTIC dome dacarbazine Bayer Pharm Inc. for the treatment with patients with advanced melanoma. 2) NDA 21-661 RSR-13-injection(efaproxiral sodium) Allos Therapeutics Inc. proposed idication for use as an adjent to whole brain radiation therapy in the treatment of brain metastases from primary breast cancer. On May 4, the committee will discuss safety concerns associated with Aranesp (darbepoetin alpha) Amgen Inc. and (eloetin alpha) Ortho Biotech both of which are indicated for treatment of anemia associated with cancer hemothearapy. 3) colorectal cancer endpoints as a follow up to the November workshop.

 

       
Location: Hilton Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 3/17/04-3/17/04

Meeting Details:

The subcommittee will 1) safety monitoring in clinical studies enrolling children w/ cancer. 2) the use of nonclinical data to supplement clinical data for evaluation of cancer therapies.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/16/03-12/16/03

Meeting Details:

The committee will discuss: (1) General issues on clinical trial design and endpoints; and (2) non-small cell lung cancer endpoints as a follow up to issues discussed at an April 15, 2003, FDA workshop.

 

       
Location: HOL-B Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 10/9/03-10/9/03

Meeting Details:

On October 9th, the committee will consider off patten oncology drugs for which pediatric studies are needed and discuss the availablity of information concerning the safe and effective use of the drugs in the pediatric population, whether additional information is needed and whether the new pediatric studies concerning the drugs may produce health benefits. Also the committee will discuss age appropirate formulation changes to facilitate dosing of products used in the pediatric oncology setting.

 

       
Location: HOL - SS Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Drugs AdComm

Meeting Date: 7/15/03-7/15/03

Meeting Details:

The committee will discuss (1)Pharmaco genetic testing for TPMT efficancy in patients for whom treatment with 6-MP is considered. (2) Overcoming challenges in pediatric oncologic product development regulatory oversight of multinational clinical studies.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsODAC

Meeting Date: 3/12/03-3/13/03

Meeting Details:

The committee will discuss new drug applications approved in an open session on March 12 and 13, 2003, to: (1) review the status of phase IV clinical studies; (2) identify difficulties associated with completion of phase IV commitments; and (3) provide advice to sponsors to assist in the planning and execution of post-marketing commitments of newly approved drugs. On March 12, 2003, the committee will discuss phase IV commitments of: (1) new drug application (NDA) 50-718 Doxil® (doxorubicin HCl, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) for the treatment of Kaposi's Sarcoma in AIDS patients with disease that has progressed on prior combination therapy or in patients who are intolerant to such therapy; (2) NDA 50-718/S-006 Doxil® (Doxorubicin HCl, Johnson and Johnson Pharmaceutical Research & Development, L.L.C.) for the treatment of metastatic ovarian cancer in patients with disease that is refractory to both paclitaxel and platinum-based chemotherapy regimens; (3) biologics license application (BLA) 97-1325 Ontak® (deneluekin diftitox, Ligand Pharmaceuticals) for the treatment of persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor; and (4) NDA 20-221/S-002, Ethyol® injection (amifostine, MedImmune Oncology, Inc.) for treatment of non-small cell lung cancer. On March 13, 2003, the committee will discuss phase IV commitments of: (1) NDA 21-174, Mylotarg® (gemtuzumab ozogamicin, Wyeth-Ayerst Laboratories, Inc.) for the treatment of CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy; (2) NDA 21-041, Depocyt® (cytarabine, SkyePharma, Inc.) for the intrathecal treatment of lymphomatous meningitis; (3) NDA 21-156 Celebrex® (celecoxib, Pharmacia Corporation) indicated in the reduction number of adenomatous colorectal polyps in familial adenomatous polyposis patients; and (4) NDA 21-029, Temodar® (temozolomide, Schering Corporation) for the treatment of adult patients with refractory anaplastic astrocytoma.

 

       
Location: HOL - Bethesda Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncology Drugs AdComm

Meeting Date: 3/4/03-3/4/03

Meeting Details:

The committee will discuss the pediatric labeling for Oncology Products.

 

       
Location: FDA Fishers Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 12/17/02-12/18/02

Meeting Details:

On December 17, the committee will discuss biologics licensing application BL STN 125011/0, Bexxar®, Tositumomab (Anti-B1) and Iodine-131-Tositumomab, Corixa Corporation, indicated for the treatment of patients with relapsed or refractory low-grade, follicular or transformed low-grade, B-cell non-Hodgkin’s lymphoma (NHL) including patients with rituximab refractory follicular non-Hodgkin’s lymphoma. On December 18, the committee will discuss AstraZeneca’s Casodex for treatment of non-metastatic prostate cancer.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 12:30PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 10/17/02-10/17/02

Meeting Details:

The subcommittee will discuss the timing of the initiation of pediatric oncology clinical studies in a drug development program. The input from this meeting will be used in developing FDA policy to the application of the pediatric rule and the issuance of written requests under the Best Pharmaceuticals for Children Act. The input from this meeting will be used in developing FDA policy to the application of the pediatric rule and the issuance of written requests under the Best Pharmaceuticals for Children Act.

 

       
Location: Rockville, Md. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 9/24/02-9/24/02

Meeting Details:

On September 24, 2002, the committee will discuss new drug application (NDA) 21-399, IRESSA (gefitinib), AstraZeneca Pharmaceuticals LP, indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have previously received platinum-based chemotherapy.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPEDIATRIC ONCOLOGY DRUG DEVELOPMENT

Meeting Date: 7/18/02-7/18/02

Meeting Details:

The public workshop is intended to provide information for and perspective from advocacy groups, interested health care providers, academia, and industry organizations on various aspects of drug development in pediatric oncology, including prioritization of new and emerging therapeutic alternatives, clinical trial design, and access to new therapeutic agents. The input from this public workshop will be used in developing topics for discussion at future meetings of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 3/12/02-3/12/02

Meeting Details:

The subcommittee will discuss potential conflicts of interest in pediatric oncology clinical trials, off-protocol patient access to investigational drugs, and access to investigational drugs for nonclinical studies.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 2/27/02-2/27/02

Meeting Details:

The committee will discuss: (1) Trial design considerations and appropriate patient populations for studies of investigational agents for adjuvant therapy of melanoma given the availability of an approved agent for this indication; and (2) the appropriate study design and control for the proposed phase 3 trial of investigational new drug (IND) 2885, MELACINE (melanoma vaccine), Corixa Corp., for adjuvant treatment of melanoma.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 1/31/02-1/31/02

Meeting Details:

The committee will discuss supplemental new drug application (NDA) 21-386, ZOMETA (zoledronic acid for injection), Novartis Pharmaceuticals Corp., indicated for the treatment of bone metastases in patients with multiple myeloma, breast cancer, prostate cancer and other solid tumors.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/5/01-12/6/01

Meeting Details:

On December 5, 2001, the committee will discuss: (1) The development of diagnostic immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays intended to identify patients who might benefit from treatment with a particular therapeutic product, with a focus on the characterization and interpretation of assay results; and (2) biologics licensing application 1037925008, a labeling supplement for HERCEPTIN (trastuzumab), Genentech, Inc., indicated for the treatment of patients with metastatic breast cancer who have tumors which overexpress HER-2. The proposed labeling supplement would include the use of FISH testing using the PATH VYSION HER-2 DNA Probe Kit, Vysis, Inc., as a diagnostic method to select patients for HERCEPTIN therapy. On December 6, 2001, the committee will discuss: (1) postmarketing safety issues associated with the use of CAMPTOSAR Injection (irinotecan hydrochloride injection), Pharmacia & Upjohn Co., combined with 5FU/leucovorin (``Saltz'' regimen) approved for the first-line treatment of patients with metastatic colorectal cancer. Potential labeling changes and issues regarding clinical trials to address the relevant safety and efficacy concerns will be discussed; and (2) supplemental new drug application (NDA) 20-637/S016, GLIADEL Wafer (carmustine), Guilford Pharmaceuticals, Inc., indicated for use as a treatment to significantly prolong survival and maintain overall function (as measured by preservation of Karnovsky Perfomance Status) and neurological function in patients with malignant glioma undergoing primary and/or recurrent surgical resection.

 

       
Location: S.S., MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 11/28/01-11/28/01

Meeting Details:

The subcommittee will discuss the implementation of the pediatric rule with regard to study designs, ethical and developmental considerations, and extrapolation of findings from adult to pediatric cancer patients.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 9/10/01-9/11/01

Meeting Details:

On September 10, 2001, the committee will discuss: (1) Clinical trial designs for first-line hormonal treatment of metastatic breast cancer; and (2) new drug application (NDA) 21-236, IntraDose (cisplatin/epinephrine) Injectable Gel, Matrix Pharmaceutical, Inc., indicated for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck in patients who are not considered curable with surgery or radiotherapy. On September 11, 2001, the committee will discuss: (1) Biologics license application (BLA) 125019, ZevalinTM (ibritumomab tiuxetan), IDEC Pharmaceuticals Corp., indicated for the treatment of patients with relapsed or refractory low grade, follicular or CD20+ transformed B cell non-Hodgkins lymphoma (NHL) and rituximab refractory follicular NHL; and (2) supplemental NDA 20-637/S016, Gliadel Wafer (carmustine), Guilford Pharmaceuticals, Inc., indicated for use as a treatment to significantly prolong survival and maintain overall function (as measured by preservation of Karnovsky Perfomance Status) and neurological function in patients with malignant glioma undergoing primary and/or recurrent surgical resection.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee / Oncologic Drugs Advisory Committee

Meeting Date: 6/28/01-6/28/01

Meeting Details:

The subcommittee will discuss parameters used for extrapolation from the adult to the pediatric setting in solid tumors and malignancies of the central nervous system.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 6/7/01-6/7/01

Meeting Details:

The committee will discuss single patient use of nonapproved oncology drugs and biologics. This is a continuation of the discussion started at the December 13 and 14, 2000 meeting.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Sub-Committee of ODAC

Meeting Date: 4/24/01-4/24/01

Meeting Details:

The subcommittee will discuss parameters used for extrapolation from the adult to the pediatric setting in the hematological malignancies of leukemia and lymphoma.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/13/00-12/14/00

Meeting Details:

---- Day 1 ---- On December 13, 2000, the committee will discuss: (1) New drug application (NDA)20-726/S-006, Femara (letrozole) Tablets, 2.5 mg, Novartis Pharmaceuticals Corp., indicated as first-line therapy in postmenopausal women with advanced breast cancer; and (2) NDA 21-240, histamine hydrochloride injection (1 mg/ml), Maxim Pharmaceuticals, Inc., indicated for adjunctive use with interleukin-2 (aldesleukin) in the treatment of adult patients with advanced metastatic melanoma that has metastasized to the liver. ---- Day 2 ---- On December 14, 2000, the committee will discuss: (1) Biologics license application (BLA) 99-0786, Campath, (alemtuzumab), Millenium and Ilex Partners, LP., and Millenium Pharmaceuticals, indicated for the treatment of patients with chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy; and (2) single patient exemptions to the use of nonapproved oncology drugs and biologics.

 

       
Location: Bethesda, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 3/16/00-3/17/00

Meeting Details:

On March 16, 2000, the committee will discuss: (1) New drug application (NDA) 21-063, Eloxatin(oxaliplatin), Sanofi Pharmaceuticals, Inc., indicated for the first-line treatment of patients with advanced colorectal cancer in combination with 5-U based chemotherapy; and (2) NDA 20-571/SE1-009, Camptosar Injection (irinotecan hydrochloride injection), Pharmacia and Upjohn Co., indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. On March 17, 2000, the committee will discuss NDA 21-174, gemtuzumab zogamicin, Wyeth-Ayerst Laboratories, indicated for the treatment of patients with CD33 positive acute myeloid leukemia in relapse.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 2/10/00-2/10/00

Meeting Details:

The Quality of Life Subcommittee of the Oncologic Drugs The Advisory Committee will discuss issues related to the study of quality of life for patients enrolled in cancer trials. Specific potential areas for discussion include definition of patient centered outcomes, clinical significance and interpretation of study results, and approaches to the statistical analysis of data.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 12/13/99-12/14/99

Meeting Details:

On December 13, 1999, the committee will discuss: (1) New drug application (NDA) 21-055, Targretin (bexarotene) Capsules, 75 milligrams, Ligand Pharmaceuticals, Inc., indicated for the treatment of patients with all clinical stages (IA-IVB) of cutaneous T-cell lymphoma (CTCL) in the following categories: Patients with early stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL, and patients with refractory advanced stage CTCL; and (2) NDA 20-449/S-011, Taxotere(docetaxel) for Injection Concentrate, Rhone-Poulenc Rorer Pharmaceuticals, Inc., indicated for the treatment of patients with locally advanced or metastatic Non-small Cell Lung Cancer after failure of prior chemotherapy. On December 14, 1999, the committee will discuss: (1) The design and analysis of active control clinical trials; and (2) NDA 21-156, Celebrex(celecoxib), G. D. Searle & Co., indicated for the regression and prevention of adenomatous polyps, which may lead to the development of colorectal cancer in patients with familial adenomatous polyposis.

 

       
Location: Holiday Inn Bethesda, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 9/16/99-9/17/99

Meeting Details:

On Sept. 16, the committee will discuss UFT (tegafur and uracil)Capsules, Bristol-Myers Squibb Co. with leucovorin calcium tablets, for the first-line treatment of metastatic colorectal cancer; and EvacetTM (doxorubicin HCl liposome injection), The Liposome Co., Inc., indicated for the first-line treatment of metastatic breast cancer in combination with cyclophosphamide. On Sept. 17, the committee will discuss TAXOL (paclitaxel) Injection, Bristol-Myers Squibb Co., indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard combination therapy; Roferon-A, Hoffman-La Roche Inc., indicated for use as adjuvant treatment of surgically resected malignant melanoma without clinical evidence of nodal disease, American Joint Committee on Cancer stage II (Breslow thickness1.5 millimeter, N0). In addition, FDA will provide an update on the preliminary results of EST 1690(ECOG intergroup study of INTRON A for the adjuvant treatment of melanoma) for discussion by the committee.

 

       
Location: Holiday Inn Kennedy Grand Ballroom 8777 Georgia Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 6/7/99-6/8/99

Meeting Details:

The committee will discuss: (1) The use of time-to-progression as the primary endpoint in breast cancer drug trials; and (2) new drug application (NDA) 21-010, epirubicin hydrochloride for injection, Pharmacia and Upjohn Co., indicated for use as a component of adjuvant therapy in patients with evidence of axillary-node-tumor involvement following resection of primary breast cancer (Stage II & III). Epirubicin is indicated for the therapy of patients with locally advanced or metastatic breast cancer. On June 8, 1999, the committee will discuss: (1) NDA 50-718/S-006, Doxil (doxorubicin HCl liposome injection), Alza Corp., indicated for the treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel- and platinum-based chemotherapy regimens and who may also be refractory to topotecan. Refractory is defined as a patient having progressive disease while on treatment, or within 6 months of completing treatment; and (2) NDA 20-221/S-012, Ethyol (amifostine) for injection, U.S. Bioscience, Inc., indicated for use to reduce the incidence and severity of radiation induced xerostomia.

 

       
Location: Town Center Hotel Maryland Ballroom 8727 Colesvi Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 3/23/99-3/23/99

Meeting Details:

On March 23, 1999, the committee will discuss new drug application -(NDA)21-051 Temodal® (temozolomide) Capsules, Schering Corp., indicated for the treatment of patients with advanced metastatic malignant melanoma.

 

       
Location: Bethesda Holiday Inn Versailles Ballroom 8120 Wi Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 1/12/99-1/13/99

Meeting Details:

On January 12, 1999, the committee will discuss: (1) New drug application (NDA) 21-029, Temodal (temozolomide) Capsules, Schering Corp., indicated for the treatment of adult patients with malignant glioma (glioblastoma multiforme and anaplastic astrocytoma) at first relapse, and (2) NDA 50-766 Prograf(tacrolimus) capsules, 1 milligram (mg) and 5 mg, and Prograf (tacrolimus) injection 5 mg (for IV infusion only), Fujisawa Healthcare, Inc., indicated for the prophylaxis of graft-versus-host disease in patients receiving allogenic bone marrow transplants. On January 13, 1999, the committee will discuss: (1) NDA 20-954 Busulfex (busulfan) Injection, Orphan Medical, Inc., indicated for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation. Diseases in which patient benefit from this mode of therapy has been demonstrated include acute lymphocytic leukemia, acute nonlymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia, non-Hodgkins lymphoma, Hodgkins disease, multiple myeloma, myelodysplastic syndrome, breast cancer, ovarian cancer, and genetic diseases, and (2) NDA 20-765 OraTest(tolonium chloride), Zila, Inc., an oral rinse that is indicated for use as a diagnostic adjunct in patients with oral lesions suspected or known to be malignant, to help in detection of all sites of cancer, definition of borders or cancerous lesions, and selection of sites to be biopsied.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 11/16/98-11/16/98

Meeting Details:

On November 16, 1998, the committee will discuss: (1) new drug application (NDA) 20-886 Panretin® (alitretinoin) Gel 0.1%, Ligand Pharmaceuticals Incorporated, indicated for the first-line topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma; and (2)NDA 21-041 DepoCyt™ (cytarabine liposome injection), DepoTech Corporation, indicated for the intrathecal treatment of lymphomatous meningitis.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 9/1/98-9/3/98

Meeting Details:

NDA 20-893 MetaretTM (suramin hexasodium for injection) Parke-Davis Phamaceutical Research. Indicated for the treatment of patients with hormone refractory prostate cancer.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 6/1/98-6/2/98

Meeting Details:

On June 1, 998, the committee will discuss: 1) new drug application (NDA) 20-892 AD32 (valrubicin 40 mg/mL), Anthra Pharmaceuticals, Inc., indicated for the treatment of refractory carcinoma in situ of the urinary bladder; and 2) NDA supplement 20-449/S-005 Taxotere (docetaxel) foe Injection Concentrate, Rhone-Polenc Rorer Pharmaceuticals, Inc., indicated for the treatment of patients with locally advanced or metastatic breast cancer who have failed previous chemotherapy. On June 2, 1998, the committee will discuss: 1) biologics license application (BLA) 97-1325 ONTAKJ (denileukin diftitox).

 

       
Location: Gaithersburg Hilton, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 3/19/98-3/20/98

Meeting Details:

On March 19, the committee will discuss: (1) New drug application (NDA) supplement Gemzar(gemcitabine HCl), Eli Lilly and Co., indicated as a single agent or in combination with cisplatin for the first-line treatment of patients with locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer; and (2) NDA Xeloda M (capecitabine) tablets, Hoffman-LaRoche Inc., for the treatment of patients with locally advanced or metastatic breast cancer after failure of paclitaxel and an anthracycline-containing chemotherapy. On March 20, the committee will discuss: (1) NDA supplement Taxol (pacletaxel) injection, Bristol-Myers Squibb Pharmaceutical Research Institute, indicated as first-line therapy for the treatment of advanced carcinoma of the ovary; and (2) NDA supplement Taxol (pacletaxel) injection, Bristol-Myers Squibb Pharmaceutical Research Institute, for the treatment of non-small cell lung cancer in patients who are not candidates for potentially curative and/or radiation therapy.

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 12/18/97-12/19/97

Meeting Details:

On December 18, 1997, the committee will discuss: (1) New drug application (NDA) supplement 16-295/S-029, Droxia (hydroxyurea capsules, USP), for the treatment of sickle cell anemia in adult patients to prevent painful crises and to reduce the need for blood transfusions; and (2) NDA 20-798, Depocyt (cytarabine lipid-particle injection), for the intrathecal treatment of neoplastic meningitis of patients with solid tumors, lymphoma, or leukemia. On December 19, 1997, the committee will discuss: (1) Biologics licensing application (BLA) supplement 97-0501, Proleukin/Aldesleukin (recombinant human interlukin-2), for the treatment of adult patients with metastatic melanoma; and (2) NDA 20-806, Neomark(broxuridine for injection), for use as a cell proliferation marker to determine the labeling index in breast cancer.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 9/18/97-9/19/97

Meeting Details:

On September 18, 1997, the committee will discuss: (1) New drug application (NDA) 20-817, RivizorTM Tablets (vorozole, Janssen Research Foundation), indicated for ``the treatment of advanced breast cancer in postmenopausal women (natural or artificially-induced menopause) with disease progression following antiestrogen therapy''; and (2) NDA Supplement 20-451/S002, Photofrin (porfimer sodium, QLT Photo Therapeutics Inc.), indicated for: ``a) reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC), and b) treatment of endobronchial carcinoma in situ or microinvasive NSCLC in patients for whom surgery and radiotherapy are not indicated.'' On September 19, 1997, the committee will discuss: (1) NDA 20-826, Paxene (paclitaxel, Baker-Norton Pharmaceuticals, Inc.), ``indicated after failure of first line or subsequent systemic chemotherapy for the treatment of advanced AIDS-related Kaposi's Sarcoma''; and (2) NDA Supplement 16-295/S029, Droxia (hydroxyurea, Bristol-Myers Squibb), ``indicated in the treatment of sickle cell anemia in adult patients to prevent painful crises and to reduce the need for blood transfusions.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 6/23/97-6/24/97

Meeting Details:

On June 23, 1997, the committee will discuss: (1) New drug application (NDA) 20-709 for ZyrkamineTM (mitoguazone dihydrochloride, ILEX Oncology), indicated for treatment of AIDS (acquired immune deficiency syndrome)-related non-Hodgkin's lymphoma in patients who have been previously treated with at least one [[Page 26806]] potentially curative regimen; and (2) NDA 20-262/S-022 for Taxol for Injection Concentrate (paclitaxel, Bristol-Myers Squibb Pharmaceutical Research Institute), indicated for second-line treatment of AIDS-related Kaposi's sarcoma. On June 24, 1997, the committee will discuss: (1) NDA 20-794 for LiazalTM Tablets (liarozole fumarate, Janssen Research Foundation), indicated for treatment of advanced prostate cancer in patients who relapsed after first-line hormonal therapy; and (2) drafts of the FDA ``Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products'' and the FDA ``Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/16/96-12/16/96

Meeting Details:

The committee will discuss: (1) NDA 20- 726 Femara TM Tablets (letrozole, CGS 20267, Ciba-Geigy Corp.), for the treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status, following antiestrogen therapy; and (2) product license application (PLA) 92-0306 TICE (BCG Vaccine, Organon Teknika Corp.), for intravesical installation for prophylaxis against recurrent papillary carcinoma of the urinary bladder.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 9/11/96-9/11/96

Meeting Details:

The committee will discuss: (1) New drug application (NDA) 19-297/S-014 Novantrone for injection concentrate (mitoxantrone, Immunex Corp.), for use in combination with corticosteroids as initial chemotherapy for treatment of patients with prostate cancer after failure of primary hormonal therapy; and (2) NDA 20-660 Remisar tablets (bropirimine, Pharmacia & Upjohn Co.), for treatment of patients with bladder carcinoma in situ (CIS) after failure of Bacillus Calmette-Guerin (BCG) therapy.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 6/12/96-6/12/96

Meeting Details:

On June 13, 1996, the committee will discuss: (1) New drug application (NDA) 20-571 Camptosar TM (irinotecan hydrochloride injection, The Upjohn Co.), indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy; and (2) NDA 20-036/S-011 Aredia (pamidronate disodium for injection, Ciba-Geigy Corp.), indicated for use in conjunction with standard antineoplastic therapy for treatment of osteolytic bone metastases. On the morning of June 14, 1996, the committee will discuss NDA 20-637, Gliadel Wafer (polifeprosan 20 with carmustine, Guilford Pharmaceuticals), indicated for use as an adjunct to surgery to prolong survival in patients with a malignant glioma.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 4/19/96-4/19/96

Meeting Details:

The committee will discuss: (1) New drug application (NDA) 20-671, Hycamtin TM injection (topotecan HCl, SmithKline Beecham) for treatment of ovarian cancer after failure of first-line therapy; and (2) an update for the Committee on FDA Oncology activities, including the Cancer Liaison Program.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/14/95-12/14/95

Meeting Details:

The committee will discuss: (1) FDA oncology initiatives, (2) new drug application (NDA) 20-587, Sterile Aerosol Talc (Talc of Luzenac PR 784, Bryan Corp.), for treatment of malignant pleural effusion, and (3) product license application (PLA) 94-0308, NR-LU-10 Fab (Karl Thomae GmbH), for primary staging of patients with biopsy confirmed small cell lung cancer.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 10/16/95-10/17/95

Meeting Details:

On October 16, 1995, the committee will discuss: (1) NDA 20-497, Fareston (toremifene, Orion Corp.) for treatment of advanced breast cancer in postmenopausal women and (2) NDA 20-541, Arimidex (anastrozole, Zeneca Pharmaceuticals) as ``a selective aromatase inhibitor for the treatment of postmenopausal women with advanced breast cancer who develop progressive disease while receiving tamoxifen.'' On October 17, 1995, the committee will discuss: (1) NDA 20-449, Taxotere (docetaxel, Rhone-Poulenc Rorer) for treatment of ``patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed; prior therapy should have included an anthracycline unless clinically contraindicated,'' and (2) product license application 91-0209, CEA-Scan TM (arcitumomab, Immunomedics, Inc.) ``for diagnostic imaging in pre-surgical patients who are being considered for resection of recurrent/metastatic colorectal cancer and, in combination with standard diagnostic modalities (SDM), for more accurate localization of carcinoembryonic antigen (CEA)-producing colorectal cancers.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 7/24/95-7/25/95

Meeting Details:

On July 24, 1995, the committee will discuss: (1) NDA 20-036, Aredia (pamidronate disodium for injection, Ciba Pharmaceuticals Division, Ciba-Geigy Corp.), ``for the treatment of bone metastases associated with multiple myeloma,'' and (2) NDA 20-509, Gemzar (gemcitabine hydrochloride, Eli Lilly), ``as first line treatment for patients with advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas,'' and ``for patients with 5-FU- refractory pancreatic cancer.'' On July 25, 1995, the committee will discuss product license application PLA 94-0799 IntronA, (interferon alpha 2b, recombinant, Schering, Inc.), for ``post- operative adjuvant therapy in malignant melanoma.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 6/8/95-6/9/95

Meeting Details:

On June 8, 1995, the committee will discuss: (1) New drug application (NDA) 50-704, Daunoxome Injection (liposomal daunorubicin, Vestar, Inc.) ``as the primary therapy for the palliative management of advanced, HIV-associated Kaposi's Sarcoma,'' and (2) NDA 20-449, Taxotere (docetaxel, Rhone-Poulenc Rorer), for treatment of ``patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed; prior therapy should have included an anthracycline unless clinically contraindicated.'' On June 9, 1995, the committee will discuss NDA 20- 221, Ethyol (amifostine injection, U.S. Bioscience, Inc.) ``as a cytoprotective agent against the cumulative renal toxicities associated with cisplatin and the cumulative hematologic toxicity associated with cyclophosphamide and cisplatin in patients with advanced solid tumors of non-germ cell origin.''

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 2/14/95-2/14/95

Meeting Details:

The committee will discuss in the order listed: (1) NDA 50-718, Dox-SL (pegylated liposomal doxorubicin hydrochloride, Liposome Technology, Inc.) for AIDS-related Kaposi's Sarcoma in patients who have failed prior systemic combination chemotherapy either due to progression of disease or unacceptable toxicity; and (2) NDA 20-515, Zoladex (goserelin acetate implant, Zeneca Pharmaceuticals Group) for palliative treatment of advanced breast cancer in pre- and perimenopausal women.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 12/12/94-12/13/94

Meeting Details:

On December 12, 1994, the committee will discuss: (1) NDA 20-212, Zinecard TM (dexrazoxane for injection, Pharmacia, Inc.) ``for preventing/reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in patients who have received potentially cardiotoxic doses of doxorubicin and who, in their physician's opinion, would benefit from continuing therapy with doxorubicin,'' and (2) NDA 20-221, Ethyol (amifostine injection, U.S. Bioscience, Inc.) ``as a cytoprotective agent against both the acute and cumulative hematologic and renal toxicities associated with alkylating agents such as cyclophosphamide, and platinum agents such as cisplatin, in patients with ovarian cancer.'' On December 13, 1994, the committee will discuss: (1) NDA 20-449, Taxotere (docetaxel, Rhone-Poulenc Rorer), for treatment of ``patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed; prior therapy should have included an anthracycline unless clinically contraindicated,'' and ``patients with locally advanced or metastatic non-small cell lung cancer even after failure of platinum-based chemotherapy,'' and (2) NDA 20-438, Vesanoid TM (tretinoin, all-trans retinoic acid, Hoffmann-La Roche, Inc.) ``for the treatment of patients with acute promyelocytic leukemia (APL)'' * * * ``for induction of remission in patients who are resistant to or are contraindicated for anthracycline-based chemotherapy or have relapsed after entering remission induced by chemotherapy.''

 

       
Location: December 12 and 13, 1994, 8 a.m., Parklawn Bldg, conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs

Meeting Date: 9/12/94-9/12/94

Meeting Details:

The committee will discuss: (1) New drug application (NDA) 20-452, Photofrin (Sterile Porfimer Sodium, QLT Phototherapeutics, Inc.), ``for the reduction of obstruction and palliation of dysphagia in patients with completely or partially obstructing esophageal cancer.'' Closed committee deliberations. The committee will discuss trade secret and/or confidential commercial information relevant to investigational new drug applications and pending NDA's.

 

       
Location: September 12, 1994, 8 a.m., Parklawn Bldg., conference rms. D and E, FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

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Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

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Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/14-10/9/14

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Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

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Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/10/14-9/10/14

Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMethodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

Meeting Date: 9/9/14-9/9/14

Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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