Avastin Gains Full FDA Approval for Recurrent Glioblastoma
Genentech announced that the Food and Drug Administration (FDA) has granted full approval of Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy. Previously, the FDA had granted Avastin provisional approval under the accelerated approval pathway.
The conversion from provisional to full approval was based on totality of evidence of Avastin in glioblastoma, including findings from the Phase 3 EORTC 26101 study. The multicenter, randomized, open-label trial evaluated Avastin as an add-on to lomustine chemotherapy in 432 patients with previously treated glioblastoma. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) as assessed by an investigator and overall response rate (ORR).
The data showed no significant increase in OS with Avastin-based treatment (hazard ratio [HR] 0.91; P=0.4578) compared to chemotherapy alone, Avastin-based treatment increased time to disease progression or death (median PFS 4.2 months vs 1.5 months; HR 0.52, 95% CI: 0.41-0.64). Moreover, among patients taking corticosteroids at baseline (50%), more were able to completely discontinue use of corticosteroids while on treatment in the Avastin arm vs. control arm (23% vs 12%).
Avastin, an angiogenesis inhibitor, works by interfering with the tumor blood supply as it directly binds to the VEGF protein to prevent interactions with receptors on blood vessels. It is already approved for various cancers, including metastatic colorectal cancer, advanced lung cancer, kidney cancer, cervical cancer, and ovarian cancer.
For more information call (800) 821-8590 or visit Avastin.com.