FDA approves Avastin for treating aggressive brain cancer

Published: 12-May-2009

The US Food and Drug Administration (FDA) has approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.


The US Food and Drug Administration (FDA) has approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.

GBM is a rapidly progressing cancer that invades brain tissue and can have an impact on physical activities and mental abilities. It affects about 6,700 people in the US every year. Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns.

"This type of cancer is very resistant to therapy and thus challenging to treat," said Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Centre for Drug Evaluation and Research. "Avastin provides a therapy for patients with progressive GBM who have not responded to other medications."

Avastin is a monoclonal antibody that mimics the antibodies produced by the body's immune system to defend against harmful substances. The medication inhibits the action of vascular endothelial growth factor that helps form new blood vessels. These vessels can feed a tumour, helping it to grow and can also provide a pathway for cancer cells to circulate in the body.

The drug was first approved in 2004 to treat metastatic cancer of the colon or rectum and has since been approved for treatment of non-squamous, non-small cell lung cancer and metastatic breast cancer.

In two clinical trials, about 25% of patients with GBM responded to Avastin with an average duration of response of about four months.

The most serious side effects associated with Avastin are gastrointestinal perforation, wound healing complications, haemorrhage, and blood clots.

The most common adverse reactions include nosebleeds, headache and high blood pressure.

Genentech of San Francisco is the manufacturer of Avastin.

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