FDA Signs Off on Nexavar for Liver Cancer Treatment
Article date: November 30, 2007
Approved in 2005 for the treatment of advanced kidney cancer, Nexavar (sorafenib) has also just been green-lighted by the US Food and Drug Administration (FDA) for the treatment of primary liver cancer that can't be removed by surgery. It is the first targeted therapy to be approved for the disease.
"This is an important new treatment option for patients who are fighting this very difficult form of cancer," said Robert Justice, MD, director of FDA's division of drug oncology products, when the approval was announced.
Liver cancer often doesn't respond well to chemotherapy drugs, and in cases where there is tumor shrinkage, the effects are mostly short-lived.
Nexavar is the first FDA-approved drug shown to significantly improve overall survival. In a randomized clinical trial of 602 people, patients taking Nexavar lived an average of about 10.7 months compared to about 7.9 months for those taking a placebo. The most common side effects include diarrhea, loss of appetite, fatigue, rash, elevated blood pressure, and a skin condition called hand-foot reaction, which can cause redness, pain, swelling, or blisters on the palms of the hands or soles of the feet.
Nexavar, which comes in 200 mg tablets, is made by Bayer HealthCare and Onyx Pharmaceuticals. It works by blocking certain kinases (proteins) that trigger cancer cells to divide and control the growth of new blood vessels that feed cancer tumors. By interfering with the action of these proteins, the drug can inhibit the growth of cancer cells.
According to Cancer Facts and Figures 2007, an estimated 19,160 new cases (13,650 in men and 5,510 in women) of primary liver cancer will be diagnosed in the United States this year. Liver cancer is many times more common in developing countries in Africa and East Asia than in the United States, because hepatitis B and C infections, which are primary risk factors for the disease, are seen more often in those regions.
Reviewed by: Members of the ACS Medical Content Staff
ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.
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