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Avastin lung cancer sBLA

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Genentech is requesting priority review of an sBLA supporting a first-line non-small cell lung cancer claim for Avastin (bevacizumab). The new claim, submitted April 10, is based on an 878-patient trial that showed a 25% improvement in overall survival for patients on Avastin plus paclitaxel and carboplatin versus chemotherapy alone. Another sBLA in metastatic breast cancer is slated for submission during the second quarter. In October, Genentech discontinued an Avastin trial in ovarian cancer following reports of high gastrointestinal perforation rates (1Pharmaceutical Approvals Monthly October 2005, p. 14)...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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