FDA Approves First Angiogenesis Inhibitor to Treat Colorectal Cancer

FDA NEWS RELEASE

FOR IMMEDIATE RELEASE

P04-23

February 26, 2004

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FDA Approves First Angiogenesis Inhibitor to Treat Colorectal Cancer

FDA today approved Avastin (bevacizumab) as a first-line treatment for patients with metastatic colorectal cancer - cancer that has spread to other parts of the body. Avastin, a monoclonal antibody, is the first product to be approved that works by preventing the formation of new blood vessels, a process known as angiogenesis. Avastin was shown to extend patients' lives by about five months when given intravenously as a combination treatment along with standard chemotherapy drugs for colon cancer (the "Saltz regimen" also known as IFL). IFL treatment includes ironotecan, 5-fluorouracil (5FU) and leucovorin.

Avastin is a genetically engineered version of a mouse antibody that contains both human and mouse components.

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