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Incyte’s Retifanlimab Tests US FDA’s Tolerance For Low Response Rates In Accelerated Approval

 
• By Bridget Silverman

US FDA advisory committee votes 13-4 to wait for Phase III data in anal cancer, expected in 2025.

Wait sign (source: shutterstock)
• Source: Shutterstock

The US FDA’s Oncologic Drugs Advisory Committee stayed focused on overall response rate when voting against the accelerated approval of Incyte Corporation’s retifanlimab for platinum-experienced anal cancer patients on 24 June.

Only four advisory committee members supported the accelerated approval pathway for retifanlimab, while 13 members agreed that a regulatory decision “should be deferred until further data are available from clinical trial

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