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The U.S. Food and Drug Administration Thursday granted wider approval to Novartis AG's (NVS, NOVN.VX) Afinitor to treat non-cancerous kidney tumors that don't require immediate surgery.
Afinitor was first approved in the U.S. in 2009 to treat kidney cancer after treatment with other drugs fail. Afinitor was approved Thursday to treat kidney tumors that are caused by a rare genetic disese called tuberous sclerosis complex, or TSC.
According to FDA, the disease causes the growth of various non-cancerous tumors in the brain, kidney and other vital organs. It affects about 40,000 patients in the U.S., the majority of which develop kidney problems. TSC generally causes multiple tumors in both kidneys, which eventually cause kidney failure and bleeding.
Afinitor, a pill taken once daily, blocks the uncontrolled activity of a protein called mTOR, which plays a role in the development and growth of certain tumors. Afinitor is also approved to treat certain kinds of brain and pancreatic tumors.
The FDA said the approval of Afinitor for use in treating kidney tumors from TSC was based on a study involving 118 patients. About two-thirds of the patients received Afinitor and one-third were received a placebo, or fake pill. Patients receiving the placebo later had the option to receive Afinitor if their kidney tumors grew.
FDA said the study showed about 42% of patients treated with Afinitor experienced "substantial" shrinkage of their tumors which lasted more than five months on average. None of the patients on the placebo had tumor shrinkage. Novartis is being required to keep following patients in the study for at least four years.
FDA said the most common side effects with Afinitor were sore mouth, nausea or vomiting, skin problems, cough, headache, diarrhea, abdominal pain, joint pains, swelling of legs or arms, and upper respiratory infections.
-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; firstname.lastname@example.org