18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious and life-threatening conditions. 

It is granted based on substantial evidence that a surrogate or intermediate endpoint is “reasonably likely to predict clinical benefit” using a totality of evidence. 

This pathway has recently entered the spotlight because of several key regulatory events: the FDA’s approval of the controversial Alzheimer’s treatment, aducanumab; the voluntary withdrawal or planned withdrawal of anticancer drug indications from four drugs that failed to demonstrate a survival benefit in confirmatory trials; and an Oncologic Drug Advisory Committee meeting that reviewed six additional anticancer indications whose trials did not confirm benefits but were still on the products’ labels.

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