The application seeks to expand the indication for the drug which is currently approved only as a first-line treatment of metastatic colorectal cancer in combination with chemotherapy.
The latest submission is based on results of a multicenter phase III trial with 829 patients with advanced or metastatic colorectal cancer whose disease progressed following previous treatment with 5-FU and irinotecan-based chemotherapy. The study showed that patients who received Avastin had a 25% reduction in the risk of death.
“Data from this study showed that adding Avastin to chemotherapy is an important treatment for patients with relapsed metastatic colorectal cancer,” said Dr Hal Barron, senior vice president, development and chief medical officer at Genentech. “We continue to investigate Avastin in clinical trials in more than 20 cancer types.”
Avastin is a therapeutic antibody designed to inhibit vascular endothelial growth factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, a process that is thought to be critical to a tumor’s growth and metastasis.