The FDA has granted accelerated approval of Avastin (bevacizumab, from Genentech) for patients with glioblastoma with progressive disease following prior therapy. The accelerated approval program allows provisional approval of medicines for cancer or other life-threatening diseases.
This approval was based on results from a Phase II open-label, multicenter, non-comparative study of 167 patients with glioblastoma that had progressed following initial treatment. Patients received Avastin monotherapy or Avastin in combination with irinotecan. The primary endpoint was an improvement in objective response rate. Tumor responses were observed in 26% of the 85 patients treated with Avastin alone, with a median duration of 4.2 months. These results were supported by a second study in which tumor responses were observed in 20% of 56 patients treated with Avastin alone, with a median duration of 3.9 months. Currently, no data are available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with Avastin in glioblastoma.
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