Genentech had previously been granted provisional approval for Avastin, according to a statement from the Roche subsidiary. The U.S. Food and Drug Administration (FDA) has now granted full approval for the drug, which is used to treat adults with glioblastoma. The approval has been granted for patients in which the brain tumour has progressed despite prior treatment.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning, Genentech’s Chief Medical Officer.
Avastin was previously approved in the U.S. for other applications and now has approval for nine distinct uses across six different types of cancer. The conversion to full approval was based in part on data from the Phase III EORTC 26101 study. Although the study did not demonstrate that the treatment improves survival rates, it did establish that Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone. In addition, more patients were able to stop taking corticosteroids.
“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,” explained Horning.