(This story has been posted on The Wall Street Journal Online's Health Blog at http://blogs.wsj.com/health.)
By Jennifer Corbett Dooren
Patients with soft-tissue sarcoma, a rare cancer that starts in the body's muscle or connective tissues, now have a new treatment option.
The FDA late yesterday approved GlaxoSmithKline's drug Votrient for use in patients with soft-tissue sarcoma, Dow Jones Newswires reports. This is the first new treatment in decades for the cancer. The National Cancer Institute estimates 11,000 cases of soft tissue sarcoma are diagnosed each year in the U.S.
Votrient, a tablet taken orally, is already on the U.S. market to treat advanced kidney cancer. It was approved to treat several subtypes of advanced soft-tissue sarcoma, after prior chemotherapy.
Votrient's approval follows the March recommendation of an agency advisory panel that the drug's benefits outweighed its risks. Clinical data involving 369 patients showed the drug temporarily slowed tumor growth but it isn't clear if the drug prolongs lives.
And the FDA notes that Votrient carries the agency's toughest warning on its label, telling patients and doctors about the potentially fatal liver damage. Patients should be monitored for liver function and treatment halt if liver function declines, the agency says.
Separately Thursday, the FDA granted wider approval to Novartis's 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 to treat kidney tumors that are caused by a rare genetic disease called tuberous sclerosis complex, or TSC, which affects about 40,000 Americans.
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