Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Committee Meeting December 4, 2012 8:00 a.m. to 5:30 p.m. Agenda: 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 (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.