July 12 was a very good day for Novartis AG.
FDA’s Oncologic Drugs Advisory Committee unanimously recommended approval (10-0) of the company’s CAR-T immunotherapy CTL019 (tisagenlecleucel). (Also see "Novartis'...
Kite’s Axi-Cel CAR-T: No Adcomm, No Problem
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Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.
Learn what's happening at the US FDA. On the go.
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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.
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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.
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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.
