FDA approves Avastin for metastatic breast cancer

February 22, 2008

SOUTH SAN FRANCISCO -The Food and Drug Administration granted accelerated approval for Avastin (bevacizumab), in combination with Taxol (paclitaxel) chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer.

The approval is based on the phase III study E2100 that showed Avastin in combination with Taxol resulted in a 52 percent reduction in the risk of disease progression or death compared with those treated with Taxol alone. The combination also doubled progression-free survival. The safety profile of Avastin was consistent with previous trials and no new safety signals were observed.

Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the agency 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.

E2100 was a multicenter, randomized and controlled clinical trial that enrolled 722 patients with previously untreated, locally recurrent or metastatic breast cancer. Patients were randomized to receive weekly treatment with Taxol with or without Avastin. Patients treated with Avastin plus Taxol experienced median PFS of 11.3 months versus 5.8 months in the Taxol alone arm. A secondary endpoint of overall survival was 1.7 months longer in the Avastin-containing arm; however, this improvement did not reach statistical significance.

Women receiving Avastin for metastatic breast cancer are eligible for the Avastin Patient Assistance program that provides free Avastin for the remainder of a 12-month period to patients (approximately $55,000), regardless of insurance coverage.

Avastin is a therapeutic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein, a potent source of angiogenesis. Angiogenesis is a process that connects tumors to the blood supply. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, which is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, wound healing complications, neutropenia and infection, and congestive heart failure. The most common severe adverse reactions.

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 United States in 2007.