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Avastin gets US approval for kidney cancer

FDA approves Avastin for the treatment of metastatic renal cell carcinoma

Roche has received US Food and Drug Administration (FDA) approval for the use of Avastin plus interferon alpha for people with metastatic renal cell carcinoma, the most common form of kidney cancer in the US.

In 2009, approximately 13,000 Americans will die from kidney cancer which, according to the American Cancer Society, is the eighth most commonly diagnosed cancer in the US.

Regulatory approval is based on data from pivotal phase III study AVOREN in 649 patients with advanced, previously untreated metastatic renal cell carcinoma. The study revealed that patients who received Avastin plus interferon alpha lived longer without the disease worsening compared to those who received interferon alpha alone: 10.2 months versus 5.4 months, respectively.

Avastin is an antibody that specifically binds to and blocks vascular endothelial growth factor (VEGF), a key driver of tumour angiogenesis. The drug's mode of action helps to control tumour growth and metastases with only a limited impact on side effects of chemotherapy.

In Europe, Avastin is approved for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. In the US, the drug was the first anti-angiogenesis therapy to be approved by the FDA and is approved for the treatment of five tumour types: colorectal cancer, NSCLC, breast cancer, glioblastoma and renal cell carcinoma.  

4th August 2009


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