Liver Cancer Drug Gains Approval in China

China's State Food and Drug Administration (SFDA) recently approved the drug Nexavar for the treatment of liver cancer, more specifically hepatocellular carcinoma, which accounts for 90 percent of all liver cancer cases. The drug, made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, is the only oral targeted therapy shown to significantly improve overall survival in patients with the disease. "We are proud to be at the forefront of liver cancer treatment with Nexavar and are hopeful that patients in China can potentially have their lives extended by treatment with Nexavar," said Gunnar Riemann, Ph.D., member of the Executive Committee of Bayer HealthCare.

The SFDA based their approval on two international Phase III double-blind, placebo-controlled trials involving more than 800 patients who received no prior systemic therapy. This approval is extremely significant for China, considering that more than 340,000 new cases of liver cancer are diagnosed in the country each year. If caught in the early stages, surgery and liver transplants can offer a cure, but most cases are only detected in the intermediate or terminal stages, when life expectancy falls to an average of four to six months. In a statement, Dr. N. Anthony Coles, president and chief executive at Onyx said, "This is another significant milestone in a region where patients are in dire need of a therapy that improves survival. The approval for liver cancer in China comes less than two years after the approval for advanced kidney cancer and proves that Nexavar is and will continue to be an important foundational therapy in multiple patient populations."

Nexavar's main ingredient, sorafenib, is from a new class of cancer treatments known as kinase inhibitors, which work by deactivating the enzyme that triggers tumor cell growth or cell division. Rather than destroying existing cancer cells, the drug is designed to subdue tumor growth. Bayer explains the process: "Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth."

The drug is already approved in the United States for both liver and advanced kidney cancer. Overall, it has been approved by at least 40 countries for liver cancer and 70 countries for advanced kidney cancer. The drug makers are also evaluating Nexavar as a treatment in other cancers, including breast and lung cancer, metastatic melanoma, and as an adjuvant therapy for kidney cancer.

In 2002, there were 600,000 deaths worldwide due to liver cancer; 370,000 occurred in China, South Korea and Japan, while the European Union reported 57,000 deaths and the United States saw 13,000 deaths.