Bayer, Onyx Submit sNDA for Nexavar

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. have submitted a sNDA to the FDA for Nexavar for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved for the treatment of advanced kidney cancer. The companies are also planning a Phase III study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA is based on positive data from the international, Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44% in patients with HCC versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.