Incyte’s Retifanlimab Tests US FDA’s Tolerance For Low Response Rates In Accelerated Approval
US FDA advisory committee votes 13-4 to wait for Phase III data in anal cancer, expected in 2025.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Oncology Accelerated Approval In Spotlight (Again) With US FDA AdComm Review Of Incyte Retifanlimab For Anal Cancer
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.