Avastin (bevacizumab) Approved By FDA For Treatment Of Aggressive Brain Cancer

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Main Category: Neurology / Neuroscience
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 09 May 2009 - 0:00 PDT

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The FDA (Food and Drug Administration, USA) approved Avastin (bevacizumab) for patients with GBM (glioblastoma multiforme) whose cancer carries on progressing after standard therapy. GBM is a rapidly progressing cancer - it invades brain tissue and can may have a significant effect on a patient´s mental abilities and physical activities. Approximately 6,700 people each year in the USA are affected by GBM.

Unfortunately, the cancer nearly always comes back, even when treated with surgery, radiation and/or chemotherapy.

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

Avastin is a monoclonal antibody that is produced in the laboratory. It mimics the antibodies our immune system produces to combat harmful substances. Avastin reduces the action of vascular endothelial growth factor that helps in the development of new blood vessels which can nourish a tumor and help it grow. The new blood vessels may also become a pathway for the cancer cells to spread around the body.

Avastin was first approved in 2004 by the FDA for the treatment of metastatic cancer of the colon or rectum. It has subsequently been approved to treat non-squamous, non-small cell lung cancer and metastatic breast cancer.

Two clinical trials showed that approximately one quarter of all patients with GBM responded to Avastin with an average duration of response of about 4 months.

Avastin´s most serious side effects include, gastrointestinal perforation, wound healing complications, hemorrhage, and blood clots - some of these side effects can be fatal. Other side effects include severe hypertension (high blood pressure), nervous system and vision disturbances, lower white blood cell counts, infection, myocardial infarction, stroke, and kidney problems. Common side effects include nosebleeds, hypertension, runny nose, headache, excess urine protein, alteration of taste, rectal bleeding, excessive tearing, dry skin, and skin peeling.

Genentech Inc. of San Francisco manufactures Avastin.

Source: FDA

Written by Christian Nordqvist


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