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The U.S. Food and Drug Administration has approved Afinitor® oral tablets (everolimus) for the treatment of patients with advanced renal cell carcinoma that has progressed after treatment with Sutent® (sunitinib) or Nexavar® (sorafenib).

The kidneys are filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney.

Sutent and Nexavar are targeted drugs that have improved outcomes among patients with advanced RCC. When these drugs fail, however, it’s important to have effective alternatives to offer to patients.

Afinitor is an oral targeted therapy that works by inhibiting a protein known as the mammalian target of rapamycin (mTOR). The mTOR protein plays an important role in the growth, division, and metabolism of cancer cells.

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The study that formed the basis for the approval of Afinitor was the Phase III RECORD-1 (__RE__nal __C__ell cancer treatment with __O__ral __R__AD001 given __D__aily) trial. The trial compared Afinitor to placebo among more than 400 patients with advanced RCC that had progressed after prior treatment with Sutent, Nexavar, or both sequentially. Survival without tumor growth or death was 4.9 months among patients treated with Afinitor compared with 1.9 months among patients treated with placebo.

The most common adverse reactions to treatment were inflammation inside of the mouth, infections, weakness, fatigue, cough, and diarrhea.

Patients with advanced RCC that has progressed after prior treatment with Sutent or Nexavar may wish to talk with their physician about the risks and benefits of Afinitor.

Reference: Novartis Media Release. Afinitor approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib. Available at: (Accessed March 30, 2009).

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