Genentech, Inc. supplemental Biologics License Application (sBLA) with the US FDA for Avastin (bevacizumab) in combination with taxane chemotherapy for patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer. Genentech has requested priority review of the application, which means that if accepted, the FDA would make its decision on the application within six months of the agency's receipt of the submission, or in November 2006. Avastin is currently approved as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.
The sBLA submission is based on results from a randomized, controlled, multicentre phase III trial (E2100) that enrolled 722 patients with previously untreated, locally recurrent or metastatic breast cancer. The trial assessed treatment with paclitaxel, a standard chemotherapy, with or without Avastin, and the primary endpoint was progression-free survival (PFS). In the trial, patients treated with Avastin plus paclitaxel had a 52 per cent reduction in the risk of disease progression or death, based on a hazard ratio of 0.48, compared to those treated with paclitaxel alone.
"In this study, Avastin, when added to paclitaxel chemotherapy, doubled the time that women with metastatic breast cancer lived without their cancer advancing, without significant added toxicities, compared to patients who received only paclitaxel," Kathy Miller, associate professor of medicine, Indiana University School of Medicine and principal investigator for the study said adding, "This is the first time progression-free survival has been observed beyond one year in a phase III US clinical trial in patients with metastatic breast cancer."
"These data support that Avastin, which is designed to interfere with the blood supply to tumors, may be an important part of treating metastatic breast cancer," said Hal Barron senior VP, development, and chief medical officer at Genentech. "This submission marks an important milestone in our ongoing effort to develop innovative therapies for breast cancer patients and to address unmet medical needs," he added.
The trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), under a Cooperative Research and Development Agreement between NCI and Genentech, Inc., and was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).