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

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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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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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ClinicalTrials.gov: https://clinicaltrials.gov

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