Afinitor (everolimus, from Novartis) tablets, a once-daily mTOR inhibitor, has been FDA approved for patients with advanced renal cell carcinoma (RCC) after treatment failure with Sutent (sunitinib, from Pfizer) or Nexavar (sorafenib, from Bayer and Onyx).

This approval was based on clinical study data that showed that Afinitor, when compared with placebo, more than doubled the time without tumor growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and reduced the risk of disease progression or death by 67%. Additional data showed that after 10 months of treatment with Afinitor, approximately 25% of patients still had no tumor growth.

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