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Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

 
• By Sue Sutter

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’  

Package wrapped
FDA wants cancer drug sponsors to think of studies supporting accelerated approval and confirmatory trials as a single package. • Source: Alamy

The US Food and Drug Administration is asking cancer drug sponsors to think about the studies intended to support accelerated approval, as well as those aimed at confirming clinical benefit postapproval, as a single package when bringing their development plans to the agency.

The goal is to have an early, comprehensive discussion with the agency to ensure that appropriate data are generated for accelerated approval and the confirmatory trials are completed in a timely fashion, Oncology Center of Excellence director Richard Pazdur said at a Friends of

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