May 12 2022

TimeEastern Time Zone

10:00 am - 3:30 pm

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting

On May 11, 2022, the subcommittee will discuss the development of a conceptual framework that will inform the decision-making of the FDA on sponsor plans and requests for waivers of early pediatric investigations of molecularly-targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development, recognizing that the rarity of pediatric cancers may preclude the feasibility of investigations of multiple products. Investigation of more than one product may be appropriate when specific product characteristics predict an improved benefit-risk assessment that warrants clinical investigation.

On May 12, 2022, the subcommittee will consider and discuss the potential utility and steps to validation of an intermediate clinical endpoint, response to induction therapy, in the development of new drugs for the first-line treatment of patients with high-risk neuroblastoma. The European Medicines Agency (EMA) has also been invited to present on both days.


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