Genentech Inc announced that the U.S. Food and Drug Administration (FDA) has designated Avastin (Bevacizumab, rhuMAb-VEGF) as a Fast Track development program for the treatment of previously-untreated first-line metastatic colorectal cancer patients.
Avastin is an investigational therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis (the formation of new blood vessels to the tumor) and maintenance of existing tumor blood vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis.
"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 Susan D. Hellmann, Genentech's executive vice president, Development and Product Operations, and chief medical officer. "The Fast Track designation will allow for a rolling submission of our potential Biologics License Application (BLA) for Avastin which allows for ongoing submission of materials that can facilitate the review process. We plan to have further discussions with the FDA in order to determine the appropriate information needed for the BLA submission."
Genentech submitted an application with the FDA for Fast Track designation based on positive results from a Phase III randomized and blinded study presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO). The multi-center study enrolled more than 900 patients, and randomized 800 patients to receive either Avastin plus the standard of care chemotherapy (5-FU/Leucovorin/CPT-11, called IFL) or the IFL regimen plus an Avastin placebo. A third arm of the study treated 110 patients with Avastin plus 5-FU/Leucovorin chemotherapy. This arm was dropped, as pre-specified, once adequate safety with the IFL regimen was established.
Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.