The four-hour virtual public meeting featured "incompatible" views of the FDA and sponsor on the OCEAN data, not to mention signs of impatience and resentment, with each side criticizing the positions of the other over the safety and efficacy of the multiple myeloma drug.
US Food and Drug Administration advisory committee meetings often can be dull affairs, with the product sponsor and agency reviewers methodically presenting their analyses of the data at hand before the FDA’s external experts discuss and vote on the matter.
However, the Oncologic Drugs Advisory Committee’s recent re-evaluation of the benefit-risk profile for Oncopeptides AB’s alkylating agent Pepaxto (melphalan...
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.
