Meeting Details:

The committee will discuss new drug application (NDA) 212306 for selinexor tablets, application submitted by Karyopharm Therapeutics Inc. The proposed indication (use) for this product is in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti- CD38 monoclonal antibody.

Meeting Details:

On March 8, 2019, the committee will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid. These approaches will take into consideration scientific data generated since the approval of the first High Risk (HR) HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection. Topics to be addressed at the meeting include clinical study design and comparator methods. Additionally, the committee will discuss potential changes to the HR HPV device indications for use considering continually evolving cervical cancer screening guidelines. The committee will provide expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics and make recommendations for future HR HPV device evaluation strategies that are both scientifically rigorous and least burdensome.

Meeting Details:

On March 21, 2019, the committee will discuss and make recommendations on clinical information related to the de novo request for the NeuroAD Therapy System by Neuronix, Ltd. The NeuroAD Therapy System is intended to provide concurrent neurostimulation and cognitive training for the treatment of mild to moderate Alzheimer's dementia.

Meeting Details:

The committee will discuss new drug application (NDA) 208646, submitted by AllerQuest, LLC, for a skin-test kit (proposed trade name PRE-PEN Plus) that combines the approved product PRE-PEN (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic acid, and amoxicillin sodium, for the proposed indication to detect IgE sensitization to penicillin antigens and reliably rule out the potential for immediate life- threatening penicillin allergic reactions with a high degree of probability in patients with history of possible IgE-dependent penicillin allergy. The discussion will include study design considerations, the contribution of each of the components, and whether the submitted data provide substantial evidence of efficacy.