Industry Presses FDA For More Specificity On Lung Cancer Study Endpoints
Pharmaceutical manufacturers are pushing FDA to define and quantify what it considers to be a “substantial and robust” progression-free survival benefit in the context of lung cancer clinical trials.
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Among the many lessons that cancer drug sponsors should take away from the Avastin proceedings is that if they hope to secure approval on the basis of a progression-free survival endpoint, in certain settings, they need to bolster that data with quality-of-life assessments.
Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin’s (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how FDA expects the magnitude of PFS benefit to be defined.