Votrient Approved to Treat Cancer That Begins in Soft Tissue
This type of tumor originates in soft tissue such as a muscle, fat, or fibrous tissue, the agency said in a news release. About 10,000 cases of soft tissue sarcoma are reported each year in the United States.
Votrient works by inhibiting angiogenisis, the production of new blood vessels that fuel tumor growth. The drug's safety and effectiveness were evaluated in clinical studies involving 369 people with soft tissue sarcoma who had undergone chemotherapy. Among people who took Votrient, the disease didn't progress for an average of 4.6 months, compared to 1.6 months among people who took an inactive placebo.
The most common side effects of Votrient included fatigue, diarrhea, nausea, weight loss, high blood pressure and decreased appetite. The drug's label will carry a "black box" warning of the potential for severe liver damage, which could be fatal. People who are given the drug should have their liver function monitored, the agency said.
Votrient was first approved in October 2009 to treat advanced kidney cancer. The drug is marketed by GlaxoSmithKline, based in Research Triangle Park, N.C.
Medline Plus has more about this drug.
Posted: April 2012