Quality-Of-Life Data Take On Added Significance With Avastin Debate
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.
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With two trials failing to show a survival advantage in first-line glioblastoma, the company must go to FDA with a progression-free survival benefit and quality-of-life data from one trial to support its accelerated approval in the advanced setting.
Genentech’s bevacizumab was the subject of one study supporting use in cervical cancer and one failing to show an effect in first-line brain cancer. A separate study repeated the disappointing brain cancer results, but the sponsor sees a silver lining in the quality of life dataset.