Background Analysis: US FDA Advisory Committee to Consider Pediatric Written Requests for AbbVie’s ABT-414 and Eisai’s Lenvatinib – NOV 19, 2015 (ODAC)
The U.S. FDA has scheduled a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) Meeting for Thursday, November 19, 2015. Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two 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) ABT-414, sponsored by AbbVie, Inc., and (2) Lenvatinib, sponsored by Eisai, Inc.