Oncologic Drugs Advisory Committee members generally agreed with GSK that a randomized study in dMMR/MSI-H patients would not be feasible; despite the favorable vote, panelists still raised concerns about use of 12-month clinical complete response as the primary endpoint.
GSK plc’s proposal for use of single-arm trials to support accelerated approval of Jemperli (dostarlimab-gxly) in locally advanced rectal cancer gained backing from a majority of a US Food and Drug Administration advisory committee members on 9 February, despite reservations about the proposed primary endpoint.
Eight of the 13 members of the Oncologic Drugs Advisory Committee said a proposed single-arm, multicenter, Phase II study, in...
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.
