publication date: Dec. 8, 2017
Drugs and Targets FDA grants Avastin full approval for glioblastoma
Genentech, a member of the Roche Group said the FDA has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy.
Avastin was previously granted an accelerated approval in this setting (The Cancer Letter, April 3, 2009).
This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the phase III EORTC 26101 study. Avastin is now approved in the United States for nine distinct uses across six different types of cancer.
EORTC 26101 is an independent phase III, multicenter, randomized, open-label trial, conducted by the European Organization for Research and Treatment of Cancer, that evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma. The primary endpoint of the study was overall survival, and progression-free survival as assessed by investigator and overall response rate were key secondary endpoints.
Results showed the following:
There was no significant increase in OS with Avastin-based treatment (HR=0.91, p=0.4578).
As the primary endpoint was not met, all secondary endpoints should be considered descriptive only.
Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months vs. … Continue reading FDA grants Avastin full approval for glioblastoma
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