In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.
A US Food and Drug Administration panel reached starkly different conclusions on whether Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Company’s Opdivo (nivolumab) should retain accelerated approval indications for second-line treatment of hepatocellular carcinoma.
At its 29 April meeting, the Oncologic Drugs Advisory Committee unanimously voted in favor of Keytruda keeping the indication pending...
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.
