In advisory committee briefing documents, the US FDA said control data was not comparable to the single-arm trial and the benefits of the monoclonal antibody were unclear.
Questions about the comparability of Y-mAbs Therapeutics Inc.’s external control data in its I-omburtamab clinical trial suggest US Food and Drug Administration approval may be difficult to achieve.
I-omburtamab, a radiolabeled murine monoclonal antibody, is proposed as a treatment for central nervous system/leptomeningeal (CNS/LM) metastases in pediatric patients...
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.
