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

Nature Reviews Clinical Oncology volume 18, pages 397–398 (2021)Cite this article

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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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Acknowledgements

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

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Authors and Affiliations

  1. Program on Regulation, Therapeutics and Law (PORTAL), Brigham and Women’s Hospital, Harvard Medical School, Boston, USA

    Bishal Gyawali & Aaron S. Kesselheim

  2. Department of Oncology, Department of Public Health Sciences and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Canada

    Bishal Gyawali

Authors
  1. Bishal Gyawali
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  2. Aaron S. Kesselheim
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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 18, 397–398 (2021). https://doi.org/10.1038/s41571-021-00504-1

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