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Afinitor approved for advanced kidney cancer

The US Food and Drug Administration has approved Novartis' mTor inhibitor Afinitor for patients with advanced renal cancer

The US Food and Drug Administration has approved Novartis' mTor inhibitor Afinitor (everolimus) for patients with advanced renal cancer whose disease has developed after treatments with other cancer therapies.

Renal cell cancer is the most common type of kidney cancer. It is resistant to standard treatments such as radiation therapy and chemotherapy and the initial treatment is often surgery to remove the kidney.

Afinitor provides patients with another option. It is a kinase inhibitor that interferes with cell communication preventing tumour growth. It is intended for patients who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets). Afinitor blocks mTOR, a protein in the cancer cell that controls tumour cell division and blood vessel growth.

The approval is based on studies that showed Afinitor, compared with a placebo, more than doubled the time without tumour growth or death in patients with advanced kidney cancer and reduced the risk of disease progression or death by 67 per cent. Additionally, after 10 months of treatment with Afinitor, approximatey 25 per cent of patients still had no tumour growth.

Joe Jimenez, CEO of Novartis Pharma said: "Afinitor is a drug that really has the potential to treat many different cancers… This will be a substantial drug for Novartis."

31st March 2009

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