Briefing Summary: US FDA Posts Advisory Committee Materials About Pediatric Written Requests For Three Investigational Cancer Drugs – DEC 11, 2014 (ODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, December 11, 2014 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) Meeting. The committee will be presented with information to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) Ganetespib, application submitted by Synta Pharmaceuticals Corp. (Synta) (2) Etirinotecan, application submitted by Nektar Therapeutics (Nektar), and (3) RO5503781, application submitted by Hoffmann-La Roche, Inc. (Roche).