The United States Food and Drug Administration (FDA) has approved Genentech’s agent Avastin (bevacizumab) for the treatment of advanced breast cancer. Specifically, the indications include Avastin, in combination with Taxol® (paclitaxel) for patients with metastatic human epidermal receptor 2-negative (HER2-negative) breast cancer who have not received prior chemotherapy for metastatic disease.
The somewhat surprising approval comes following the ODAC recommendation for rejection of this indication.
The approval was prompted by an improvement in progression-free survival of 5.5 months with Avastin/Taxol over Taxol alone, with no demonstration of a survival improvement with Avastin.
Avastin is already approved for colon and lung cancer.