FDA Approval Alert: Bevacizumab Granted Full Approval for Type of Brain Cancer

12/07/17

The US Food and Drug Administration (FDA) has given full approval to a drug for the treatment of adults with a recurrent type of brain cancer that has progressed following prior therapy.

Bevacizumab (Avastin, Genentech) was previously granted provisional approval for recurrent glioblastoma under the FDA’s accelerated approval program.

Full approval was given to bevacizumab in this setting after results from the phase III EORTC 26101 study were reported. In 432 patients with previously treated glioblastoma, bevacizumab-based treatment increased the time to disease progression or death compared to chemotherapy alone (median progression-free survival, 4.2 vs 1.5 months; HR, 0.52; 95% CI, 0.41-0.64).

Additionally, researchers reported that adverse events were consistent with those seen in previous trials of bevacizumab across tumor types for approved indications.

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“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, MD, CMO and Head of Global Product Development, Genentech, in a press release (December 6, 2017). “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.”—Zachary Bessette