US FDA advisory committee votes 13-4 to wait for Phase III data in anal cancer, expected in 2025.
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...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
