Oncologic Drugs Advisory Committee asked to weigh in on adequacy of GSK’s proposal for two single-arm trials to support accelerated approval in a curative setting, as well as the potential novel use of clinical complete response as an approval endpoint.
The US Food and Drug Administration is seeking external input on whether GSK plc’s proposed clinical development program for Jemperli (dostarlimab) in rectal cancer will generate adequate data to support accelerated approval and subsequent confirmation of the drug’s clinical benefit in this setting.
In a briefing document released ahead of a 9 February Oncologic Drugs Advisory Committee meeting, the agency raises a...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
