‘Dangling’ Accelerated Approvals: US FDA Flags Concerns About ‘Marginal’ Response Rates

 
• By Sue Sutter

Failed confirmatory trials for PD-1/L-1 inhibitor indications raise questions about marginal response rates in single-arm trials used to support accelerated approval, Oncology Center of Excellence leaders say in NEJM article that explains why the agency is taking six of these indications to its Oncologic Drugs Advisory Committee.

Dangling mugs
US FDA's Oncology Center of Excellence has coined the term "dangling accelerated approvals" when confirmatory trials fail to verify clinical benefit but indications remain on the label. • Source: Shutterstock

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