Posted 20 June 2017
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June 20, 2017 – Endocrinologic and Metabolic Drugs Advisory Committee
The Committee will discuss a supplemental new drug application (sNDA) for Vicotza (liraglutide) injection, sponsored by Novo Nordisk, for the proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk.
June 21-22, 2017 – Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
July 11, 2017 – Oncologic Drugs Advisory Committee
The Committee will discuss a BLA for Mylotarg (gemtuzumab ozogamicin) for intravenous use, submitted by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. The proposed indication (use) for this product is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML).
July 12, 2017 – Oncologic Drugs Advisory Committee
The Committee will discuss a BLA for tisagenlecleucel-T suspension for intravenous use. The application was submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).
July 13, 2017 – Oncologic Drugs Advisory Committee
During the morning session the Committee will discuss a BLA for ABP 215, a proposed biosimilar to Genentech/Roche's AVASTIN (bevacizumab), submitted by Amgen Inc.
During the afternoon session, the Committee will discuss a BLA for MYL-1401O, a proposed biosimilar to Genentech Inc.'s HERCEPTIN (trastuzumab), submitted by Mylan GmbH.
The Committee will discuss potential pediatric development plans/written requests for APX-005M by Apexigen; PMO1183 (lurbinectedin) by PharmaMar USA Inc.; ASP2215 (gilteritinib) by Astellas; Prexasertib by Dista Products/Eli Lilly; and olaratumab by Eli Lilly.
July 28, 2017 - Vaccines and Related Biological Products Advisory Committee
Dynavax Technologies Corporation has announced an Advisory Committee meeting for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)].