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.

Car gas and brake pedals

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...

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