Results Wire: US FDA Advisory Committee Discusses Pediatric Written Requests For Three Investigational Cancer Drugs – DEC 11, 2014 (ODAC)
On Thursday, December 11, 2014 the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) was 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 discussed 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 provided information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration were: (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.