Briefing Summary: US FDA Posts Advisory Committee Materials About Potential Pediatric Written Requests for ABT-414 and Lenvatinib – NOV 19, 2015 (ODAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, November 19, 2015, Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). 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.

See the SAC Tracker report