Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while data on overall survival are still incomplete or immature, with too few deaths for meaningful analysis.
The investigators aimed to evaluate whether clinical trials with immature survival data generated evidence of overall survival benefit during the period after marketing authorisation, and where that evidence was reported.
