Unusual meeting agenda indicates that effectiveness of tisagenlecleucel-T in acute lymphoblastic leukemia is not a primary issue for US FDA advisory committee consideration at first-ever review of a CAR-T therapy; agency's draft questions focus on product quality considerations and measures for mitigating risk of cytokine release syndrome.
US FDA briefing documents on Novartis AG's tisagenlecleucel-T (CTL109) suggest the first advisory committee review of a CART-T therapy will focus more on product quality considerations, safety and risk mitigation measures than on clinical efficacy.
The Oncologic Drugs Advisory Committee will meet July 12 to consider tisagenlecleucel-T (formerly CTL109) for the treatment of pediatric and...
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.
