I'm not sure the numbers required. I posted a lin
Post# of 154851
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Posted On: 12/03/2019 12:44:34 PM
I'm not sure the numbers required. I posted a link before of approvals. I will try to find it, but some were very short approvals. Also interestingly, an study of all accelerated approvals from 97 to 17, only 20% went on to increase OS. Maybe if leronlimab gets this approval, it can help push up that 20% number.
https://jamanetwork.com/journals/jamainternal...ct/2733561
https://jamanetwork.com/journals/jamainternal...ct/2733561
Quote:
Findings 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 preapproval trials.
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