AACR 2024 – US accelerated approvals come under more fire
While the FDA has been toughening its stance on accelerated approvals, prompting some drug withdrawals, and pressuring sponsors to have confirmatory trials well under way, questions about this pathway persist. A new analysis, presented at AACR over the weekend and published in JAMA, has criticised the regulator for converting accelerated approvals to full green lights in the absence of any survival benefit, and called on companies to be forced to run confirmatory trials with robust, “clinically meaningful endpoints”. This analysis was funded by the political pressure group Arnold Ventures, which calls for lower prescription drug costs, and looked at the 59 oncology drugs given accelerated US approvals across 129 indications in 2013-17. 48 of these indications have subsequently been converted to full approval, but just 19 were on the basis of OS; 21 used another survival metric, and the analysis called out seven drugs formally converted on the back of remission rates alone. The FDA has previously been criticised for allowing drugs to remain on the market in the absence of a confirmatory trial – so-called dangling accelerated approvals – and an earlier analysis suggested that just 14% of cancer drugs given accelerated nods in 2008-12 later showed an OS benefit.
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