Roche group Genentech has announced full US approval for Avastin for the treatment of adults with glioblastoma that progressed following prior therapy.
The drug was granted an accelerated approval back in 2009 on the back of Phase II data showing that tumours were reduced to at least half their original size in 28 percent of patients.
The conversion to full approval was based on the totality of evidence of Avastin (bevacizumab) in glioblastoma, including data from the Phase III EORTC 26101 study.
While the trial failed to meet its primary endpoint of an improvement of overall survival when Avastin was added to lomustine chemotherapy, the Avastin-based therapy did increase the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months versus 1.5 months).
Also, among people taking corticosteroids at baseline (50 percent), more people were able to completely stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm (23 percent vs. 12 percent).
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, chief medical officer and head of Global Product Development.
“Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options.”
Avastin is now approved in the US for nine distinct uses across six different types of cancer.
