SAN FRANCISCO, Feb. 22 (UPI) -- The U.S. Food and Drug Administration has granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for treatment of breast cancer.
Genentech Inc. said the treatment is designed for patients with metastatic HER2-negative breast cancer who have not received chemotherapy.
The approval was based on a Phase III study that showed Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to treatment with paclitaxel alone, and a doubling in progression-free survival, Genentech said Friday in a release.
The accelerated approval program allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data.
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