FDA approves new drug for deadly kidney cancer

[March 31, 2009]  WASHINGTON (AP) -- A drug from Novartis has won U.S. approval as a treatment for patients with kidney cancer that has returned after treatment with older drugs.

The Food and Drug Administration approved the pill on Monday to treat renal cell cancer, the most common form of kidney cancer.

The agency said patients tested with Novartis' Afinitor lived more than twice as long without tumor growth as those who didn't receive the drug. The study by the Swiss drugmaker showed Afinitor delayed tumor growth nearly 5 months, compared with less than two months for patients not taking the drug.

Afinitor works by blocking a protein that helps cancer cells divide and grow. The drug was approved for patients who have already taken Pfizer Inc.'s Sutent and Bayer's Nexavar.

Kidney cancer is resistant to chemotherapy and radiation therapy, and the most effective remedy is usually to surgically remove the kidney. When the cancer is isolated to the kidney, a majority of patients will survive at least five years. If the cancer has spread to other parts of the body, the survival rate is much shorter.

About 13,000 patients died from the disease last year, according to the American Cancer Society.

Basel, Switzerland-based Novartis has submitted the drug for approval in the European Union, Japan and elsewhere.

Shares of Novartis fell 47 cents to close at $36.55 Monday.

[Associated Press]

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