Novartis’ Afinitor® (everolimus) has been approved by the United States Food and Drug Administration for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib) or Nexavar® (sorafenib).

Afinitor is a once-daily oral treatment that targets mTOR.

The FDA regulatory filing for Afinitor was based on the results of the Phase III RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial. The trial compared Afinitor to placebo among patients with advanced RCC that had progressed after prior treatment with Sutent, Nexavar, or both sequentially. Afinitor significantly improved progression-free survival.

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