Recent FDA reviews of cemiplimab and sintilimab combined with chemotherapy for patients with advanced-stage non-small-cell lung cancer reached discordant outcomes, as cemiplimab was approved and sintilimab was rejected. The applications share many serious faults, including neither serving an unmet need nor enrolling any patients from the USA. We argue that the FDA criteria should be more transparent and consistent; moreover, the historical policy of the FDA to abstain from consideration of the cost of a drug perpetuates a crisis in oncology care and should be re-examined.
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Acknowledgements
The authors thank J. Pritchett (Mayo Clinic) for discussions when preparing this manuscript.
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A.D. has been an advisory board member for Amgen, Foundation Medicine and Sanofi. H.J.W. has been an advisory board member for Amgen, AstraZeneca, Boehringer–Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech/Roche, Merck, Mirati, Regeneron, Summit Therapeutics and Takeda. C.J.S. declares no competing interests.
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Desai, A., Smith, C.J. & West, H.J. Navigating approval pathways for immunotherapy in NSCLC: should criteria be revised?. Nat Rev Clin Oncol 20, 423–424 (2023). https://doi.org/10.1038/s41571-023-00761-2
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DOI: https://doi.org/10.1038/s41571-023-00761-2
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