Oncology Accelerated Approval Withdrawals: Which Indications Need Confirmation Next?

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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Since the US Food and Drug Administration introduced the accelerated approval program in 1992, the agency has granted more than 250 approvals under this expedited pathway. The program has brought a number of important therapies to market earlier than would have been expected under the regular review process, including cancer immunotherapies.

However, despite the high-profile failure of several confirmatory trials for Genentech, Inc. ’s PD-L1 inhibitor Tecentriq (atezolizumab), Merck & Co., Inc

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