Accelerated Approval Granted for Bevacizumab in Glioblastoma

he US Food and Drug Administration (FDA) granted accelerated approval of bevacizumab (Avastin) for people with glioblastoma with progressive disease following prior therapy. The effectiveness of bevacizumab in this aggressive form of brain cancer is based on an improvement in objective response rate. Currently, no data are available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab in glioblastoma.

The new indication for bevacizumab was granted under the FDA’s accelerated approval program that allows provisional approval of medicines for cancer or other life-threatening diseases. The accelerated approval is based on independently reviewed data from an open-label, multicenter, noncomparative phase II study that included 167 patients with glioblastoma that had progressed following initial treatment with temozolomide and radiation. According to an FDA analysis of the study, tumor responses were observed in 26% of the 85 patients treated with bevacizumab alone, and the median duration of response in these patients was 4.2 months.