Genentech Gets Full Approval for Avastin in Glioblastoma Patients

FDA has granted full approval for Genentech’s Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prior therapy. Avastin was previously approved under the agency’s accelerated approval program, which requires confirmatory evidence in order for it to be converted to full approval.

The approval decision was based on data from the Phase 3 EORTC 26101 study, which evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma. The primary endpoint of the study was overall survival (OS), and progression-free survival (PFS) and overall response rate were key secondary endpoints. While the results showed that there was no significant increase in OS, Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months vs. 1.5 months).