Posted by Michael Wonder on 28 May 2019
Assessment of the clinical benefit of cancer drugs receiving accelerated approval
28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have verified clinical benefit in a confirmatory trial, what constitutes the verification of benefit?
In this updated review of 93 cancer drug indications granted accelerated approval by the FDA from December 11, 1992, through May 31, 2017, confirmatory trials reported that 20% (n = 19) had improvement in overall survival, 21% (n = 20) had improvement in a different surrogate measure, and 20% (n = 19) had improvement in the same surrogate measure used in confirmatory trials and pre-approval trials.
Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials.
