According to Bayer and Onyx, Nexavar (sorafenib), an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. Nexavar is also approved in more than 60 countries for advanced kidney cancer.
The FDA approval was based on positive data from an international Phase III placebo-controlled trial which demonstrated that Nexavar improved overall survival by 44% in patients with HCC versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo.
Arthur Higgins, chairman of the executive committee of Bayer HealthCare, said: “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. 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.”