TUESDAY, Nov. 20 (HealthDay News) -- The U.S. Food and Drug Administration announced this week that it has approved the drug Nexavar (sorafenib) for use in patients with inoperable hepatocellular carcinoma. Nexavar was previously approved in 2005 for use in patients with advanced renal cell carcinoma.
A recent international, randomized controlled trial of 602 patients with inoperable hepatocellular carcinoma showed those who received Nexavar survived an average of 10.7 months compared to 7.9 months in those receiving placebo. The trial was stopped early when an interim analysis showed this survival benefit.
Nexavar is a kinase inhibitor, and appears to slow growth of tumors by limiting angiogenesis, interfering with cellular messaging within cancer cells, and affecting cell death. The most commonly seen adverse reactions include fatigue, weight loss, skin manifestations, hair loss, diarrhea, nausea and abdominal pain.
Hepatocellular carcinoma, which accounts for 80 to 90 percent of all liver cancers, typically carries a poor prognosis when the tumor cannot be surgically removed, with average survival of only three to six months. Therefore, Nexavar "is an important new treatment option for patients who are fighting this very difficult form of cancer," said Robert Justice, M.D., director of FDA's division of drug oncology products, in a statement.
Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn., and by Onyx Pharmaceuticals, Inc. of Emeryville, Calif.
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