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.
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...
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.
