Genentech, Inc announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009.
"We look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade," said David Schenkein, senior vice president, Clinical Hematology and Oncology, Genentech. "A global phase-III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later this year."
Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.