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 However, some early approvals are subsequently withdrawn. Here we discuss the insights gained from withdrawn accelerated approvals for oncologic agents in the past decade.
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Mellgard, G.S., Fojo, T. & Bates, S.E. Lessons from withdrawn accelerated approvals in oncology.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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DOI: https://doi.org/10.1038/s43018-023-00696-8
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