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# No Benefit in Many Cancer Accelerated Approvals
- URL: https://www.fdaweb.com/no-benefit-in-many-cancer-accelerated-approvals/
- Published: 2024-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:27:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156737

Harvard Medical School researchers say most cancer drugs granted FDA accelerated approval did not demonstrate benefit in overall survival or quality of life within five years of the accelerated approval. Writing in *JAMA*, the researchers conclude that “patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes.”

The study looked at 129 cancer drug-indication pairs that were granted accelerated approval from 2013 to 2023\. Fewer than half demonstrated a clinical benefit in confirmatory trials, it says.