24 April 2024 - The FDA’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.

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