RSS

FDA grants accelerated approval of Avastin

FDA grants accelerated approval of Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer

Genentech, Inc. (NYSE: DNA) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. The approval is based on a Phase III study (E2100) that showed that Avastin in combination with paclitaxel chemotherapy resulted in a 52 percent 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). The safety profile of Avastin was consistent with our previous experience and no new safety signals were observed.

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. Genentech has shared with the FDA a summary of the results from a second positive Phase III trial (AVADO), and is expecting results from a third Phase III trial (RIBBON I) in first-line metastatic breast cancer in late 2008. A full review of both the AVADO and RIBBON I data by the FDA will be required for the accelerated approval to be converted into a full approval. As a part of our commitment to fully evaluate Avastin in breast cancer, Genentech will also submit data to the FDA from three additional randomized trials that are either ongoing or planned.

“There is no cure for metastatic breast cancer so it is important to control the disease as early and for as long as possible,” said Kathy Miller, M.D., Associate Professor of Medical Oncology, Indiana University School of Medicine and lead investigator on the E2100 trial. “Now with Avastin plus paclitaxel, we can increase the time a woman’s cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone.”

“As an oncologist who has treated women with metastatic breast cancer, I know how important the first course of therapy can be,” said Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development, Genentech. “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.” Breast cancer is the second most common form of cancer and the second leading cancer killer among American women.

According to the American Cancer Society, an estimated 178,000 women were diagnosed with breast cancer and approximately 40,000 died from the disease in the U.S. in 2007. Genentech estimates that 75 percent of women with newly diagnosed metastatic breast cancer are HER2-negative.