NOV 19 ODAC

Results Wire: US FDA Advisory Committee Discusses Pediatric Written Requests For Two Investigational Cancer Drugs – NOV 19, 2015 (ODAC)

On Thursday, November 19, 2015, 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 two 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) ABT-414, sponsored by AbbVie, Inc.; and (2) Lenvatinib, sponsored by Eisai, Inc.

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