Company seeks conversion from accelerated to regular approval for the first KRAS G12C inhibitor on the market, but the agency is asking its Oncologic Drugs Advisory Committee whether the progression-free survival primary endpoint in the CodeBreaK 200 confirmatory trial can be reliably interpreted.
The US Food and Drug Administration is questioning whether the confirmatory trial for Amgen, Inc.’s Lumakras (sotorasib) was sufficiently adequate and well-controlled to verify the accelerated approval drug’s clinical benefit in non-small cell lung cancer.
In a briefing document released ahead of a 5 October meeting of the Oncologic Drugs Advisory Committee, the agency...
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
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.
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.
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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