The supplemental biologics license application (sBLA) submission is for the use of Avastin (bevacizumab) in combination with taxane chemotherapy in patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer.
The filing is based on results from a randomized, controlled, multi-center phase III trial that enrolled 722 patients with previously untreated, locally recurrent or metastatic breast cancer. The trial, which was named E2100, assessed treatment with paclitaxel 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% 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.
Genentech has requested priority review of the application, which means that, if accepted, the FDA would make its decision on the application in November.