The US Food and Drug Administration has approved a previously "Fast Track"-designated drug for treatment of advanced hepatocellular carcinoma (primary liver cancer). The drug was already approved for advanced renal cell carcinoma (primary kidney cancer).

"The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare.

The approval was given after impressive Phase III trials of its active ingredient, sorafenib, has proven that the drug gave patients an improved overall survival of 44% compared to placebo. Diarrhea and hand/foot skin reactions were the most common side effects experienced by those patients who received the drug.

"The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, M.D., chairman, board of directors, American Liver Foundation.

Hepatocellular carcinoma usually is a development of either a viral hepatitide infection (hepatitis B or C) or cirrhosis (usually because of alcoholism). HCC is the 5th most common tumor worldwide, affecting males significantly more than females.

The European Commission has already granted marketing authorization to Nexavar for HCC late last month.