FDA Gives Puts Avastin™ on Fast-Track for Possible Approval

The U.S. Food and Drug Administration (FDA) has put the experimental drug Avastin™ (Bevacizumab) on the Fast Track for possible approval for treatment of previously-untreated advanced colorectal cancer patients.

The therapeutic antibody -- designed to interfere with the blood supply that is critical to the growth and spread of tumors -- in combination with chemotherapy increases chances of survival for advanced patients by 50 percent, researchers reported at the recent American Society of Clinical Oncology meeting (see Colorectal Cancer Week story)..

"The Fast Track designation recognizes the serious unmet medical need of patients with metastatic colorectal cancer and the potential of Avastin to affect this disease," said Dr. Susan D. Hellmann, Genentech's chief medical officer.

Under the FDA Modernization Act of 1997, the Fast Track program is designed to expedite the review of a new drug that addresses unmet medical needs for the treatment of a serious or a life-threatening condition.

Other Sources: Genentech, FDA