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Genentech Avastin study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Overall survival data with Genentech's VEGF-inhibitor Avastin "suggest a stronger patient benefit than anticipated," firm reports at ASCO. Bevacizumab plus chemotherapy had a median survival of 20.3 months versus 15.6 months with chemo alone in a randomized Phase III study in previously untreated metastatic colorectal cancer patients. Hazard ratio for the 50% increased chance of survival was 0.65 (p=0.00003); the study was designed to detect a hazard ratio of 0.75, or a 33% increase in chance for survival. Avastin also met the secondary endpoints of progression-free survival, response rate and duration of response. Genentech "is currently discussing plans for the filing of a [BLA] with [FDA]"...
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