Bayer/Onyx submit US sNDA for Nexavar in HCC
German drug major Bayer and the USA's Onyx Pharmaceuticals have submitted a supplemental New Drug Application for Nexavar (sorafenib) tablets to the US Food and Drug Administration for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. The drug 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 HCC following the complete removal of early-stage liver cancer. The sNDA submission is based on positive data from the Phase III SHARP trial which demonstrated that Nexavar extended overall survival 44% in HCC patients (p=0.0006) versus placebo, with no significant differences in serious adverse event rates between the two groups.
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