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FDA approval standards for anticancer agents — lessons from two recent approvals in breast cancer

Two recent drug approvals for metastatic breast cancer highlight that the evidence standards required to support FDA approval seem to be decreasing. These two drugs not only failed to improve overall survival, but their effects on progression-free survival were also astonishingly low; in one case, the treatment delayed progression by only 3 days.

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A.S.K. acknowledges research funding from Arnold Ventures and the Harvard-MIT Center for Regulatory Science.

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Correspondence to Bishal Gyawali.

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Competing interests

A.S.K. is the Principal Investigator on a grant from FDA to Brigham and Women’s Hospital unrelated to the topic of this article. B.G. declares no competing interests.

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Gyawali, B., Kesselheim, A.S. FDA approval standards for anticancer agents — lessons from two recent approvals in breast cancer. Nat Rev Clin Oncol (2021).

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