Fully Enrolled Confirmatory Studies Can De-Risk Novel Accelerated Approval Endpoints – FDA Official

Oncology Center of Excellence Deputy Director Paul Kluetz talks about what might make a drug a good candidate for a Project Frontrunner-type development program and how sponsors might benefit from FDA’s experience with OCE’s first Project Pragmatica pilot. 

pencil erasing word risk
Novel cancer endpoints may get more regulatory leeway in context of Project Frontrunner • Source: Shutterstock

A novel endpoint for a cancer drug’s accelerated approval is more likely to get the go ahead from the US Food and Drug Administration if the sponsor has a fully accrued post-marketing study underway at the time of application, Oncology Center of Excellence Deputy Director Paul Kluetz said.

Kluetz noted this is one way in which an Oncology Center of Excellence project can help “de-risk” aspects of a...

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