Bayer/Onyx
Germany's Bayer and US drug developer Onyx' Nexavar (sorafenib) has been approved in Japan for the treatment of patients with unresectable hepatocellular carcinoma, a type of liver cancer that accounts for 95% of all liver cancer cases in the country. Nexavar is also currently available in Japan as an approved treatment for unresectable or metastatic renal cell carcinoma. The latest clearance was based on the international, Phase III, double-blind, placebo-controlled SHARP study that evaluated more than 800 patients who received no prior systemic therapy. The evaluation found that Nexavar improved overall survival in patients with HCC by 44% (p=0.0006) versus placebo. Based on the SHARP study results, Nexavar is currently approved in more than 70 countries for liver cancer, including the USA and several countries in Europe.
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