Ahead of advisory committee, FDA officials raise concerns about the PD-1 inhibitor, which was submitted on the basis of a Phase III trial conducted solely in China. OCE’s Pazdur and Singh make the case for a global, harmonized approach to cancer drug development using multiregional trials.
The US Food and Drug Administration is signaling concerns about relying on Phase III data generated in a single country ahead of a 10 February advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab in non-small cell lung cancer.
In a comment published in Lancet Oncology on 4 February, Oncology Center of Excellence leaders Harpreet Singh and Richard Pazdur...
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.
