Thursday, Jun 26, 2003
South San Francisco, Calif. -- June 26, 2003 --Genentech, Inc. (NYSE: DNA) today 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, M.D., M.P.H., 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.
Comprehensive Clinical Trial Program
Based on preclinical and clinical studies showing that VEGF plays a broad role in a range of cancers, Genentech is pursuing a late-stage clinical development program with Avastin evaluating its potential use in metastatic colorectal, renal cell (kidney), breast and non-small cell lung cancers. To date, more than 2,000 patients have been treated with Avastin in clinical studies.
The second colorectal cancer trial in progress enrolled 200 patients who are not optimal candidates for CPT-11 as a first-line treatment and randomized patients to receive either 5-FU/Leucovorin chemotherapy alone or in combination with Avastin. Two Phase III trials in metastatic kidney cancer are also scheduled to begin this year. In addition, Phase III Eastern Cooperative Oncology Group (ECOG) studies continue to evaluate Avastin in combination with chemotherapy in second-line metastatic colorectal, first-line metastatic non-small cell lung, and first-line metastatic breast cancers. Additional studies are ongoing through the National Cancer Institute in more than 20 different tumor types.
For further information about Avastin clinical trials, please call 888-662-6728.
About VEGF and Tumor Angiogenesis
For decades the link between angiogenesis and cancer growth has been discussed by many researchers, but it wasn't until 1989 that a key growth factor influencing the process, VEGF, was discovered by Napoleone Ferrara, M.D., a staff scientist at Genentech. Dr. Ferrara and his team cloned VEGF, providing some of the first evidence that a specific angiogenic growth factor existed. This research was published in the journal Science in 1989. Dr. Ferrara then created a mouse antibody to this protein. In 1993, Dr. Ferrara and his team at Genentech, in a study published in Nature, demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play a critical role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.
About Colorectal Cancer
According to the American Cancer Society (ACS), colorectal cancer is the second leading cause of cancer death in the United States and the third most frequently diagnosed cancer. The ACS estimates that 147,500 new cases of colorectal cancer will be diagnosed in the United States in 2003.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 11 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.