Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals are seeking the FDA's approval for Nexavar tablets for the treatment of patients with liver cancer.
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Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer.
The companies also confirmed that they are planning a company-sponsored phase III study of Nexavar in the adjuvant treatment of hepatocellular carcinoma (HCC) following the complete removal of early stage liver cancer.
A previous clinical trial demonstrated that Nexavar extended overall survival by 44% in patients with HCC versus placebo.