Genentech submits Avastin sBLA to US FDA

US biotechnology firm Genentech has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Avastin (bevacizumab) in combination with taxane chemotherapy for patients who have not previously received chemotherapy for their locally-recurrent or metastatic breast cancer.

The firm, which is majority-owned by Swiss drug major Roche, has requested priority review which would force the FDA to make its decision within six months, or by November at the latest. The agent is currently approved as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-fluorouracil-based chemotherapy.

The sBLA submission is based on results from a randomized, controlled, multicenter Phase III trial that enrolled 722 patients with previously-untreated, locally-recurrent or metastatic breast cancer. The trial assessed treatment with paclitaxel, a standard chemotherapy, with or without Avastin, and the primary endpoint was progression-free survival. In the trial, patients on Avastin plus paclitaxel had a 52% reduction in the risk of disease progression or death, based on a hazard ratio of 0.48, compared to those treated with paclitaxel alone, Genentech noted.