Bayer/Onyx' Nexavar cleared for HCC in China

Germany's Bayer HealthCare and the USA's Onyx Pharmaceuticals say that the State Food and Drug Administration of China has approved Nexavar (sorafenib) for unresectable or metastatic hepatocellular carcinoma. According to the firms, their drug is the first and only oral targeted therapy to significantly improve overall survival in patients with the disease. The approval was based on two international Phase III double-blind, placebo-controlled trials that evaluated over 800 patients who received no prior systemic therapy.

"China has the highest number of liver cancer patients worldwide, with more than 340,000 new cases diagnosed each year and the incidence is continuing to rise," said Gunnar Riemann, a member of the executive committee of Bayer HealthCare. Onyx chief executive Tony Coles noted that "the approval in liver cancer in China comes less than two years after the approval in advanced kidney cancer and proves that Nexavar is, and will continue to be, an important foundational therapy in multiple patient populations."

HCC is the most common form of liver cancer and is responsible for about 90% of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year, more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union and 15,000 in the USA.