FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma

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:

  • There was no significant increase in overall survival with bevacizumab-based treatment (hazard ratio [HR] = 0.91, P = .4578). As the primary endpoint was not met, all secondary endpoints should be considered descriptive only.
  • 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% confidence interval = 0.41–0.64).
  • Among people taking corticosteroids at baseline (50%), more people were able to completely stop intake of corticosteroids while on treatment in the bevacizumab arm compared to the control arm (23% vs 12%).
  • In the bevacizumab-plus-lomustine arm, 22% of people discontinued treatment due to adverse reactions compared with 10% of people in the lomustine arm.
  • Adverse events were consistent with those seen in previous trials of bevacizumab across tumor types for approved indications.

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®.


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