Can Roche Make A Case For Avastin In Brain Cancer Based On Quality Of Life?
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.
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Genentech’s bevacizumab was associated with improved maintenance of baseline quality of life and performance status in a confirmatory trial conducted under accelerated approval, but an NCI-funded study found higher rates of neurocognitive decline, increased symptom severity and decline in health-related quality of life.
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.
Work needs to be done to allow for the use of social media to support content validity of patient-reported outcomes, but one FDA endpoints reviewer says there is a place for social media to work alongside traditional methods of validating PROs.