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Study points to weaknesses in FDA accelerated approval path

April 9, 2024


That is the conclusion of a study presented at the American Association of Cancer Research (AACR) in San Diego and simultaneously published in the Journal of the American Medical Association (JAMA), looking at 46 cancer drugs given accelerated approvals over that period.

According to the authors, nearly two-thirds of them (63%) were converted to full approval by the FDA, even though only 43% showed a clinical benefit on overall survival (OS) or an increase in quality-of-life in confirmatory trials completed within the next five years. Another 15% had no results available within that period.

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