Genentech has announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for the manufacturing of Avastin™ (bevacizumab) bulk drug substance at the company's facility in Vacaville, California.
Avastin was approved by the FDA in February 2004 to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as a first-line treatment for metastatic colorectal cancer and 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.
"The FDA approval for Avastin bulk drug production at our Vacaville facility is an important step in ensuring that there is sufficient supply available for patients who need Avastin," said David A. Ebersman, senior vice president, Product Operations. "We are pleased with the successful transfer of the Avastin process and appreciate the diligent efforts by our employees and the FDA to secure the approval of this filing."
Avastin bulk drug substance will continue to be manufactured at the company's South San Francisco facility, as well as 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 licensed to produce bulk drug substance for Avastin, Herceptin® (Trastuzumab), Rituxan® (Rituximab) and Xolair® (Omalizumab).