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

Executive Summary

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.

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