Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus
US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.
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The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.
Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.