Reuters: Regulatory News: UPDATE 1-FDA approves Novartis' Afinitor for kidney tumors

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UPDATE 1-FDA approves Novartis' Afinitor for kidney tumors Apr 26th 2012, 21:03 Thu Apr 26, 2012 5:03pm EDT WASHINGTON, April 26 (Reuters) - U.S. health regulators approved on Thursday Novartis AG's Afinitor for the treatment of non-cancerous kidney tumors in patients with a rare genetic disease known as tuberous sclerosis complex. The approval from the Food and Drug Administration makes Afinitor the first drug available specifically for non-cancerous tumors that do not require immediate surgery. Tuberous sclerosis complex, or TSC, causes multiple tumors in both kidneys that compress normal tissue, leading to kidney failure and bleeding. Novartis' treatment, known generically as everolimus, is a pill taken once daily that blocks the activity of a protein that plays a critical role in the development and growth of non-cancerous tumors.

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