Fewer Than Half of Accelerated Approval Drugs Showed ClinicalBenefit in Confirmatory Trials After Five Years

Of the 46 cancer drugs that the U.S. Food and Drug Administration (FDA) granted accelerated approval between 2013-2017, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials after more than five years of follow-up, according to a study presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, held April 5-10 in San Diego. The study was simultaneously published in JAMA.

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