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A reality check of the accelerated approval of immune-checkpoint inhibitors

Nature Reviews Clinical Oncology volume 16, pages 656–658 (2019)Cite this article

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The FDA grants Accelerated Approval when deemed necessary to address an unmet need, with a promise that post-marketing research commitments will be fulfilled and that the approvals will be revisited and eventually changed if clinically meaningful results are reported. Herein, we present a timeline of all Accelerated Approvals granted to immune-checkpoint inhibitors to illustrate three ways in which the FDA has failed to fulfil their part in this social contract.

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Fig. 1: Timeline of approvals and confirmatory trials for all immune-checkpoint inhibitors (ICIs) granted Accelerated Approval as of July of 2019.

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Authors and Affiliations

  1. Division of Hematology Oncology, Oregon Health & Science University, Portland, OR, USA

    Jennifer Gill & Vinay Prasad

  2. Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA

    Jennifer Gill & Vinay Prasad

  3. Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland, OR, USA

    Vinay Prasad

  4. Center for Health Care Ethics, Oregon Health & Science University, Portland, OR, USA

    Vinay Prasad

Authors
  1. Jennifer Gill
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  2. Vinay Prasad
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Correspondence to Vinay Prasad.

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Competing interests

V.P. receives royalties from his book Ending Medical Reversal; his work is funded by the Laura and John Arnold Foundation; he has received honoraria for Grand Rounds/lectures from several universities, medical centres, nonprofit groups and professional societies; and he is a writer for Medscape and the host of the Plenary Session podcast, which receives crowdfunding support through the Patreon platform. J.G. declares no competing interests.

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Gill, J., Prasad, V. A reality check of the accelerated approval of immune-checkpoint inhibitors. Nat Rev Clin Oncol 16, 656–658 (2019). https://doi.org/10.1038/s41571-019-0260-y

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