FDA approves Nexavar for treatment of liver cancer

WAYNE, N.J., and EMERYVILLE, Calif. Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have received approval from the Food and Drug Administration for the supplemental drug application for Nexavar, for the treatment of inoperable liver cancer, according to the CNN Money Web site.

Nexavar is now the first approved systemic therapy for liver cancer. The drug was approved in 2005 for the treatment of advanced kidney cancer. The drug has now been approved for unresectable hepatocellular carcinoma, which is the most common type of liver cancer, responsible for about 90 percent of the liver tumors in adults, according to the National Library of Medicine.

“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. “This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease.”

Liver cancer is the sixth most common type of cancer in the world, affecting about 19,000 people in the U.S. each year, according to the World Health Organization and the California Cancer Clinic.

Nexavar comes in 200 mg tablets and the usual dose is two tablets taken twice a day on an empty stomach.