Background Analysis: US FDA Advisory Committee to Review Three Investigational Cancer Drugs For Pediatric Written Requests – DEC 11, 2014 (ODAC)
The US FDA has scheduled a Pediatric Oncologic Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) Meeting for Thursday, December 11, 2014. Information will be presented 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).