Genentech, the company that makes Avastin, announced the FDA's approval, calling Avastin the first new treatment for glioblastoma in more than a decade.
According to Genentech, the FDA based its approval on two clinical trials that together included more than 200 glioblastoma patients. Between 20% and 26% of patients showed a tumor response to Avastin that typically lasted for about four months.
Genentech notes that no information is available from clinical trials showing that Avastin eased disease-related symptoms or increased survival among glioblastoma patients.
According to Genentech, adverse events seen in Avastin's glioblastoma trials were in line with the drug's known risks, which include developing gastrointestinal perforations (tears in the stomach or colon), complications with wound healing, and severe or fatal bleeding.