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

 
• By Sue Sutter

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.

Time To Rethink
FDA is rethinking the accelerated approval of a host of indications for immunotherapies. • Source: Shutterstock

The US Food and Drug Administration’s extensive use of accelerated approval for checkpoint inhibitors will be on the line next month when an advisory committee weighs the future of six indications under the expedited pathway for three cancer immunotherapies that have failed to confirm clinical benefit.

The Oncologic Drugs Advisory Committee will meet 27-29 April to discuss whether to keep on label or withdraw: two indications...

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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