WASHINGTON (Dow Jones)--The Food and Drug Administration on Thursday approved GlaxoSmithKline PLC's (GSK, GSK.LN) cancer drug Votrient for use in patients with soft-tissue sarcoma, making it the first new treatment for the rare type of cancer in decades.
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. The disease starts in muscle or other connective tissues in the body.
The National Cancer Institute estimates there are about 11,000 cases of soft-tissue sarcomas diagnosed in the U.S. each year.
Votrient's approval follows the March recommendation of an agency advisory panel, which voted, 11-2, that the drug's benefits outweighed the risks. Clinical data involving 369 patients showed the drug temporarily slowed tumor growth.
Specifically, the study showed patients being treated with Votrient had a median progression-free survival of 4.6 months compared with 1.6 months on the placebo, or a difference of three months in the time before the cancer starts to worsen.
The FDA noted that Votrient carries the agency's toughest boxed warning, telling patients and health-care professionals about the potential risk of liver damage, which can be fatal. Patients should be monitored for liver function and treatment should be discontinued if liver function declines, the agency said.
The most common side effects seen in Votrient-treated patients were fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration, the FDA said.