Genentech, Inc. announced that the US Food and Drug Administration (FDA) has approved Avastin (bevacizumab) to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line-or previously untreated-metastatic cancer of the colon or rectum. Avastin is the first FDA-approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis. Genentech will begin shipping Avastin within three calendar days.

The Avastin FDA approval is based on data from two trials. The pivotal trial was a large, placebo-controlled, randomized study that demonstrated a prolongation in the median survival of patients treated with Avastin plus the IFL (5-FU/Leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). In addition, this study demonstrated an improvement in progression-free survival (PFS) of more than four months (10.6 months in the Avastin/IFL arm compared to 6.4 months in the IFL-alone arm). The survival and PFS results observed when Avastin is added to first-line chemotherapy are the longest ever reported in a randomized, Phase III study of patients with metastatic colorectal cancer.

In the pivotal trial, the most serious adverse events that occurred with Avastin included gastrointestinal perforations and wound healing complications, which were uncommon. The most common severe adverse events in this trial included hypertension, which was managed with oral medications, nosebleeds and asymptomatic proteinuria. Adverse events observed in other trials with Avastin included hemorrhage, congestive heart failure and thromboembolism.

"Today marks an important shift in the treatment of metastatic colorectal cancer, with the approval of an innovative treatment based on elegant science that targets cancer in an entirely new way," said Arthur Levinson, Genentech's chairman and chief executive officer. "The FDA's approval of Avastin would not have been possible without the dedication and passion of hundreds of Genentech employees, clinical trial investigators, patient advocates, the FDA and, most importantly, all of the colorectal cancer patients and their families who volunteered for Avastin clinical trials. We're pleased that patients diagnosed with metastatic colorectal cancer today have a new treatment option."

Avastin is a 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 a tumour, a process that is critical to a tumour's growth and metastasis.

Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a late-stage clinical development programme 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 prostate, ovarian, melanoma and several types of solid tumor cancers and hematologic malignancies.

According to the American Cancer Society, more than 150 patients die every day from colorectal cancer in the United States. Colorectal cancer is the second leading cause of cancer death in the United States, the third most frequently diagnosed cancer, and approximately 147,000 new cases of colorectal cancer will be diagnosed in the United States in 2004.