Genentech Gains FDA Approval for Brain Cancer Drug

Dec 07, 2017

Genentech, a division of Roche, announced that the U.S. Food and Drug Administration has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy. Avastin was previously granted provisional approval in this setting under the FDA's accelerated approval program.

“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options.”

This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the Phase III EORTC 26101 study. Avastin is now approved in the United States for nine distinct uses across six different types of cancer.