The FDA organization responsible for reviewing therapeutic cancer vaccines is the CBER Office of Cellular, Tissue and Gene Therapies. So I would assume that the same office will review the Provenge BLA and be responsible for deciding if a panel is needed and if so who to be on it. For an oncology product, they may/do also consult the CDER Office of Oncology for advices but I believe the final decision will be from the OCTGT. See slide 6 in the below link:
An important figure will likely be Raj Puri, Director of the Division of Cellular and Gene Therapies in OCTGT, who is also Acting Chief of the Tumor Vaccines Branch in his division. Does anyone know anything about him?
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