The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for sorafenib (Nexavar) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Sorafenib is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005, sorafenib became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.
"The approval of Nexavar in liver cancer marks the second time in 2 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."