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Oncology Accelerated Approval Withdrawals: Which Indications Need Confirmation Next?

Executive Summary

US FDA’s ‘industry-wide evaluation’ of accelerated approvals has already led to withdrawals of four PD-1/PD-L1 inhibitor indications, with the Oncologic Drugs Advisory Committee set to review another six next week. Over the next two years, an additional five indications may be up for review.

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