Opinion: Bashing accelerated approval isn’t supported by the data
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall survival (progression-free survival). Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer. So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story.
Case in point: Under the seemingly benign title, “Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval,” an article published recently in the Journal of the American Medical Association claims that among “cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15%.”
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