Bevacizumab (Avastin) previously received provisional approval from the FDA.
Genentech announced this week that the FDA granted full approval to bevacizumab (Avastin) for the treatment of previously-treated adults with glioblastoma that progressed, according to a press release.
Previously, bevacizumab was granted provisional approval under the accelerated approval program.
Glioblastoma is the most common and aggressive type of glioma, with more than 12,300 Americans diagnosed in 2017, according to Genentech.
The decision to grant full approval was based on positive findings from the phase 3 EORTC 26101 clinical trial, which investigated the efficacy of bevacizumab plus lomustine chemotherapy. Included in the study were 432 patients with previously-treated glioblastoma.
The primary endpoint of the study was overall survival (OS) and secondary endpoints were progression-free survival (PFS) and overall response rate (ORR), according to the release.
The investigators found that there was no increase in OS with the addition of bevacizumab.
Additionally, bevacizumab-based treatment increased PFS to 4.2 months compared with 1.5 months with chemotherapy alone, according to the release.
Approximately 50% of patients were taking corticosteroids at baseline. Of these patients, 23% in the bevacizumab combination cohort were able to stop corticosteroid treatment compared with only 12% of control patients, according to the study.
The investigators found that 22% of patients treated with bevacizumab discontinued treatment due to adverse reactions; however, adverse events were similar to those seen in previous trials, Genentech reported.
Common adverse events include hypertension, proteinuria, nosebleeds, rectal bleeding, back pain, headache, taste change, dry skin, inflammation of the skin and nose, and watery eyes.
Bevacizumab has been previously approved to treat multiple different cancers, including metastatic colorectal cancer, advanced nonsquamous non-small cell lung cancer, metastatic kidney cancer, glioblastoma, advanced cervical cancer, and recurrent ovarian cancer.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech. “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.”