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Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals

Executive Summary

Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.

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‘Dangling’ Accelerated Approvals: US FDA Flags Concerns About ‘Marginal’ Response Rates

Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.

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.

Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.

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