GENENTECH SUBMITS APPLICATION FOR AVASTIN
Genentech has submitted a supplemental biologics license application (sBLA) with the FDA 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 sBLA submission is based on results from a randomized, controlled, multicenter Phase III trial (E2100) 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 (PFS). In the trial, patients treated with Avastin plus paclitaxel had a 52 percent reduction in the risk of disease progression or death, based on a hazard ratio of 0.48, compared to those treated with paclitaxel alone. These results can also be stated as a doubling in overall PFS. Patients receiving Avastin plus paclitaxel had a median PFS of more than a year while patients receiving paclitaxel alone had a median PFS of approximately six months.