The National Cancer Institute-sponsored trial was designed to evaluate Avastin (bevacizumab) plus paclitaxel chemotherapy in first-line metastatic breast cancer, with the primary endpoint being an improvement in progression-free survival, compared to chemotherapy alone.
The companies plan to share the interim data with the FDA to discuss the possible filing of a supplemental biologics license application (BLA) for Avastin plus chemotherapy in first-line metastatic breast cancer. Last year Avastin was granted FDA approval as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.
“This study is very important for two reasons: it demonstrates that Avastin has clinical benefit when used in combination with chemotherapy in first-line metastatic breast cancer and reinforces our belief that targeting angiogenesis can result in patient benefit in multiple tumor types, including colorectal and non-small cell lung cancers,” said Dr Hal Barron, Genentech’s senior vice president of development and chief medical officer.
“We are particularly excited about the results in this first-line study since they occurred at an early interim analysis.”