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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

During the morning session, the committee reviewed and discussed the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List. The focus of the discussion was 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. 

During the afternoon session, information was presented to gauge interest in exploring potential pediatric development plans for ONC201.