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Lessons from withdrawn accelerated approvals in oncology

Nature Cancer volume 5, pages 211–215 (2024)Cite this article

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Drug regulatory agencies in the USA and Europe have mechanisms to provide patients faster access to novel treatments, expecting that follow-up trials will confirm clinically meaningful results. However, some early approvals are subsequently withdrawn. Here we discuss the insights gained from withdrawn accelerated approvals for oncologic agents in the past decade.

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Authors and Affiliations

  1. Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA

    George S. Mellgard, Tito Fojo & Susan E. Bates

  2. James J. Peters Department of Veterans Affairs Medical Center, Bronx, NY, USA

    Tito Fojo & Susan E. Bates

  3. Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA

    Tito Fojo & Susan E. Bates

Authors
  1. George S. Mellgard
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  2. Tito Fojo
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  3. Susan E. Bates
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Contributions

All authors made substantial contribution to researching data and articles for this work, discussions of content, generating tables and figures, writing the manuscript and editing the manuscript before submission.

Corresponding authors

Correspondence to Tito Fojo or Susan E. Bates.

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The authors declare no competing interests.

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Mellgard, G.S., Fojo, T. & Bates, S.E. Lessons from withdrawn accelerated approvals in oncology. Nat Cancer 5, 211–215 (2024). https://doi.org/10.1038/s43018-023-00696-8

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