Biologics
Genentech Announces Resubmission of Supplemental Biologics License Application for Avastin in Combination with Paclitaxel for First-Line Metastatic Breast Cancer
Published in Cancer Weekly, September 11th, 2007
Genentech, Inc. (NYSE:DNA) announced that the company resubmitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin(R) (bevacizumab), in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer. The resubmission, based on the pivotal Phase III trial E2100, marks the beginning of a six-month review period by the FDA.
In September 2006, the company received a Complete Response Letter from the FDA requesting additional information from the trial, including an independent, blinded review of patient scans for progression-free...
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Source: Cancer Weekly (2007-09-11)
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