Oncologic Drugs Advisory Committee says Karyopharm’s multiple myeloma therapy is not ready for approval based on a single arm study. US FDA says it will move quickly when randomized trial is done.
The approvability of Karyopharm’s selinexor will likely hinge on the results of an ongoing randomized trial after a majority of the US FDA’s Oncologic Drugs Advisory Committee agreed that the agency should not approve the drug based on existing data from a single-arm study in a highly refractory multiple myeloma population.
The committee voted 8-5 that approval of the drug should await the ongoing BOSTON trial. The minority vote in favor...
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.
