WebMD Medical News
Brunilda Nazario, MD
May 6, 2009 -- The FDA has approved the drug Avastin to treat a type of brain cancer called glioblastoma that progresses despite treatment with other therapies.
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.
Avastin inhibits a protein called VEGF (vascular endothelial growth factor) to curb the growth of new blood vessels that supply blood to tumors.
Avastin isn't a new drug. The FDA first approved Avastin in February 2004 to treat metastatic colorectal cancer, which is colon cancer or rectal cancer that has spread.
In October 2006, the FDA approved Avastin to treat a certain type of advanced lung cancer (advanced non-squamous, non-small-cell lung cancer) in combination with chemotherapy.
In February 2008, the FDA approved Avastin for use with chemotherapy to treat certain cases of advanced breast cancer.
Genentech has asked the FDA to consider approving Avastin to treat metastatic renal cell carcinoma, which is kidney cancer that has spread.
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.
SOURCES:News release, Genentech.FDA: "Label and Approval History: Avastin."Genentech: "Avastin."WebMD Medical Reference : "Avastin Questions and Answers."
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