Bevacizumab/Paclitaxel Granted Accelerated Approval for First-Line Breast Cancer Treatment

The US Food and Drug Administration (FDA) granted accelerated approval for bevacizumab (Avastin), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The approval is based on a phase III study (E2100) showing that bevacizumab plus paclitaxel resulted in a 52% reduction in the risk of disease progression or death compared to those treated with paclitaxel alone and a doubling in progression-free survival (PFS), based on a hazard ratio of 0.48 (P < .0001). The safety profile of bevacizumab was consistent with previous experience.

ODAC Vote Overruled

Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data. In December 2007, the FDA's Oncologic Drugs Advisory Committee voted 5 to 4 against the drug's approval for this indication (given the lack of benefit seen in overall survival), but their recommendations were overruled.

According to an August 2007 survey by Decision Resources, Inc, 79% of US oncologists were already using bevacizumab to treat breast cancer patients off-label.