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news.Genentech has reported that Avado, a Roche-sponsored Phase III, placebo-controlled study evaluating Avastin in combination with docetaxel chemotherapy met its primary endpoint of prolonging progression-free survival in patients who had not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer.
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The Avado study (BO17708) investigated the addition of Avastin administered either at 15mg/kg or 7.5mg/kg every three weeks to docetaxel chemotherapy. Both doses of Avastin in combination with chemotherapy showed statistically significant improvement in the time patients lived without their disease advancing compared to chemotherapy and placebo, based on investigator assessments.
The FDA is reviewing Genentech’s supplemental biologics license application for the use of Avastin, in combination with paclitaxel chemotherapy, for the treatment of patients who have not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer, and it is expected to make a decision by February 23, 2008.