Advisory committee will vote on whether an additional trial demonstrating applicability of results from the Phase III study in China is needed prior to approval; agency says PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer.
“Regulatory flexibility” to rely on Chinese study data for Innovent Biologics, Inc./Eli Lilly and Company's sintilimab is not warranted because the PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer and there is no evidence it provides a safety or efficacy advantage over available therapy, the US Food and Drug Administration said.
In a briefing document released ahead of a 10 February review by the Oncologic Drugs Advisory Committee, FDA staff...
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.
