Navigating approval pathways for immunotherapy in NSCLC: should criteria be revised?

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 n...

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Veröffentlicht in:Nature reviews. Clinical oncology 2023-07, Vol.20 (7), p.423-424
Hauptverfasser: Desai, Aakash, Smith, Caleb J., West, Howard Jack
Format: Artikel
Sprache:eng
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Zusammenfassung: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.
ISSN:1759-4774
1759-4782
DOI:10.1038/s41571-023-00761-2