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Oncology Accelerated Approval In Spotlight (Again) With US FDA AdComm Review Of Incyte Retifanlimab For Anal Cancer

 
• By Bridget Silverman

US FDA questions suitability of accelerated approval based on marginal response rate in a single-arm trial of Incyte’s PD-1 inhibitor candidate for relapsed squamous carcinoma of the anal canal.

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The shadow of the FDA Oncologic Drugs Advisory Committee’s epic last meeting hangs over the panel’s upcoming meeting to review Incyte Corporation’s retifanlimab-dlwr for relapsed squamous cell anal cancer – another accelerated approval bid for another PD-1/L1 inhibitor.

The ODAC will convene on 24 June for its first session since the six-indication, three-product review of “dangling” accelerated approvals for PD-1/L1 inhibitors that failed to verify clinical benefit post-approval...

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