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.
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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.
ODAC Report Card: Six Takeaways From Accelerated Approval Reviews Of Checkpoint Inhibitors
US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.
Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.