Genentech’s combination therapy receives FDA’s accelerated approval

The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy 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<0.0001). Susan Desmond-Hellmann, president, product development, Genentech, said: "New treatments are needed, and this approval provides women who have not yet received chemotherapy for their metastatic breast cancer a new option to consider with their physician and families."