FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy

May 7, 2009

While not directly related to the treatment of retinal disease, eyecare professionals might be interested to know that Genentech announced Tuesday that the U.S. Food and Drug Administration (FDA) granted accelerated approval of AvastinĀ® (bevacizumab) for people with glioblastoma with progressive disease following prior therapy.

The new indication for Avastin 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, non-comparative Phase II study that included 167 patients with glioblastoma that had progressed following initial treatment with temozolomide and radiation. Patients were randomized into two arms: Avastin alone or Avastin in combination with irinotecan. A primary endpoint of the study was objective response rate. Response was assessed by magnetic resonance imaging (MRI) and measured using World Health Organization radiographic criteria along with decreased or stable corticosteroid use. MRI does not necessarily distinguish between the tumor, swelling (edema), or tissue death (necrosis) caused by prior radiation therapy.

According to an FDA analysis of the study, tumor responses were observed in 26 percent (95% confidence interval: 17.0%, 36.1%) of the 85 patients treated with Avastin alone, and the median duration of response in these patients was 4.2 months (95% confidence interval: 3.0 months, 5.7 months).

Read the full release from Genentech.




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