Biotechnology product maker Genentech Inc. said that it received approval from the Food and Drug Administration to manufacture its Avastin colon cancer drug at the company’s Vacaville, Calif., facility.
Avastin was approved by the FDA in February 2004 to be used in combination with intravenous chemotherapy as a first-line treatment for metastatic colorectal cancer. The drug blocks blood vessel growth necessary for tumor development.
Avastin bulk drug substance will continue to be manufactured at the company’s South San Francisco facility, and at the Vacaville facility. The current Vacaville site has a manufacturing capacity of 144,000 liters and was originally licensed by the FDA in April 2000. The facility is also licensed to produce bulk drug substance for Genentech’s breast cancer treatment Herceptin and Xolair, its asthma drug developed in collaboration with Novartis AG and Tanox Inc.