The approval was based on two international Phase III double-blind, placebo-controlled trials that evaluated more than 800 patients who received no prior systemic therapy.
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.
Nexavar is said to be the first and only oral targeted therapy to significantly improve overall survival in patients with the metastatic hepatocellular carcinoma. Nexavar is currently approved in more than 40 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer.
Anthony Coles, president and CEO of Onyx Pharmaceuticals, said: “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.”