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Article: Genentech's Avastin poised for BLA. (Life Sciences).(biologics license application)
- Article from:
- Chemical Market Reporter
- Article date:
- June 9, 2003
- Author:
CopyrightCOPYRIGHT 2003 Schnell Publishing Company, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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GENENTECH INC. reported positive Phase III trial data for its anti-angiogenic drug Avastin (bevacizumab) in colorectal cancer, positioning the company to file a biologics license application (BLA) later this year.
In a Phase III trial, Avastin raised the odds of survival by 50 percent in treatment-naive metastatic colorectal cancer patients. Avastin in combination with chemotherapy extended median survival by five months compared to chemotherapy alone (20.3 versus 15.6 months). The data were released at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Genentech plans to file a BLA for Avastin with the Food and Drug ...