Monday, Dec 1, 2003
South San Francisco, Calif. -- December 1, 2003 --Genentech, Inc. (NYSE: DNA) announced today that the Biologics License Application (BLA) for Avastin& (bevacizumab) has been accepted by the U.S. Food and Drug Administration (FDA). As part of the Avastin BLA filing, Genentech requested and has been granted Priority Review designation from the FDA. Based on the Priority Review designation, the FDA has six months from the submission date, or by the end of March 2004, to take action on the BLA filing. The final portion of the BLA was submitted on September 29 under the FDA's Fast Track designation as a treatment for first-line metastatic colorectal cancer in combination with chemotherapy.
"This Priority Review designation puts us one step closer to delivering a potential new therapy to metastatic colorectal cancer patients and we will continue to work with the FDA as they review our Avastin BLA filing," said Robert L. Garnick, Ph.D., Genentech's senior vice president, Regulatory, Quality and Compliance.
About the Avastin BLA Filing
The BLA filing was based on results of the 900-patient pivotal study of Avastin plus the IFL chemotherapy regimen (5-FU/Leucovorin/CPT-11), which were announced earlier this year. The study showed that Avastin plus the IFL regimen improved median survival by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months). In this study, the addition of Avastin to chemotherapy was well tolerated. Grade 3 hypertension, managed with oral medications, was clearly increased in this Phase III study and although uncommon, gastrointestinal perforation may be increased by the addition of Avastin to chemotherapy.
About VEGF and Tumor Angiogenesis
The link between angiogenesis and cancer growth has been discussed by many researchers for decades, but it wasn't until 1989 that a key growth factor influencing the process, Vascular Endothelial Growth Factor (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.
Avastin is an investigational therapeutic antibody designed to inhibit 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 tumors, a process that is critical to tumor growth and metastasis.
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. Avastin is also being evaluated in earlier stage trials as a potential therapy in pancreatic, prostate, ovarian, melanoma and several types of solid tumor cancers and hematologic malignancies. To date, more than 2,000 patients have been treated with Avastin in clinical studies. For further information about Avastin clinical trials, please call 888-662-6728.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the second leading cause of cancer death in the United States and the third most frequently diagnosed cancer. The American Cancer Society 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 12 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 www.gene.com.