Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.
Learn what's happening at the US FDA. On the go.
More from US FDA Performance Tracker
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.
More from Regulatory Trackers
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.