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Supplemental Oncology Approvals: 'Reverse Accelerated Approval,' Not Lowering The Bar

 
• By Sue Sutter

Sometimes data supporting drug's initial approval can serve as confirmatory evidence for full approval of a subsequent indication based on an intermediate endpoint, US FDA Oncology Center of Excellence Director Pazdur says; proposed framework discussed at Friends of Cancer Research meeting would establish more systematic approach to streamlining supplemental approvals.

FDA entrance sign 2016

Granting regular approval to a supplemental oncology drug or biologic application based on an intermediate or surrogate endpoint can be a form of "reverse accelerated approval" and should not be seen as lowering the bar for demonstrating efficacy, the US FDA's top oncology drug official believes.

In some circumstances, it is appropriate to grant full approval for a supplemental indication because the initial approval essentially serves...

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