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Briefs tagged "accelerated approval"

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9 min read

Approved Early, Proven Later? What Happens to Cancer Accelerated Approvals

The FDA can put a cancer drug on the market years early, on the promise that proof will follow. We checked all 219 oncology accelerated approvals on the FDA's own lists to see how often a drug with accelerated approval goes on to get full approval.

Of 219 FDA oncology accelerated approvals, 127 (58%) have converted to full approval, 57 (26%) are still waiting and 35 (16%) were withdrawn. Conversion takes a median of 3.3 years, and conversion is not the same as proof: in a 2024 JAMA study, 63% of approvals converted but only 43% showed a clinical benefit. Folotyn has waited since 2009.

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oncologyFDAdrug developmentclinical trialsFolotynBeleodaqUkoniqKeytrudaOpdivo

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