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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

During the morning session, the committee will review and discuss the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment.  Planned introductory presentations will be on: (1) cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors.

During the afternoon session, 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) ONC201, presentation by Oncoceutics  Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.