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.

Business concept - high speed abstract MRT track of motion light for background in tokyo, japan

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...

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