On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab 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, MD, Chief Medical Officer and Head of Global Product Development at Genentech. “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 bevacizumab in glioblastoma, including data from the phase III EORTC 26101 study.
About EORTC 26101
EORTC 26101 is an independent phase III, multicenter, randomized, open-label trial, conducted by the European Organisation for Research and Treatment of Cancer (EORTC) that evaluated the addition of bevacizumab to lomustine (Gleostine) chemotherapy in 432 patients with previously treated glioblastoma.
The primary endpoint of the study was overall survival. Progression-free survival as assessed by investigator and overall response rate were key secondary endpoints.
Results showed the following:
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.