March 30, 2009

FDA OKs drug for advanced kidney failure

The U.S. Food and Drug Administration says it has approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood.

Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib (Sutent) or sorafenib (Nexavar), said Dr. Robert Justice, director of the FDA's Division of Drug Oncology Products. Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing.

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth, the FDA said. While Sutent and Nexavar are multiple kinase inhibitors that act on a number of cellular targets, Afinitor works by blocking a specific protein known as the mammalian target of rapamycin. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland.