Bayer, Onyx Submit sNDA for Nexavar

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 internat...

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