Pharma Industry
Industry: Email Alert RSS FeedGenentech's Avastin poised for BLA. (Life Sciences).(biologics license application)
Chemical Market Reporter, June, 2003 by Krause, Carey
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 Administration (FDA) by the end of 2003. "The primary and secondary efficacy endpoints, as well as...
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