Regulatory flexibility may be warranted for diseases with low prevalence in the US, such as nasopharyngeal carcinoma, or for pediatric tumors, which are difficult to study in multi-regional trials, FDA officials said at the advisory committee review of Innovent/Lilly’s lung cancer drug sintilimab; the agency has no plans to change its regulations on evaluation of foreign clinical data.
With the recent advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s Chinese-developed PD-1 inhibitor sintilimab, the US Food and Drug Administration sent a clear message that the regulatory door is closed to most cancer drug applications based solely on clinical trial data from a single country.
However, that same door remains open a crack for a limited group of products, such as those aimed at cancers...
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.
