MHLW grants priority review for Bayer's Nexavar; approves Primovist

Japan's Ministry of Health, Labor and Welfare (MHLW) has granted German drugmaker Bayer priority review status for marketing authorization of its anticancer drug product Nexavar (sorafenib) for the treatment of hepatocellular carcinoma. In addition, the contrast agent Primovist (gadoxetic acid disodium) was also cleared in the Japan for the detection and characterization of liver lesions by magnetic resonance imaging including liver tumors such as HCC, liver metastases and other malignant and benign lesions. This product is scheduled to be launched on the Japanese market in the immediate future. Nexavar, an oral anti-cancer agent, is the first and only drug shown to significantly improve overall survival in patients with HCC. In Japan, Nexavar was filed in June 2006 for the treatment of renal cell carcinoma and an additional application for HCC, was submitted in September 2007. Japan has the second largest population of liver cancer patients in the world; most of them suffer from HCC, which claims 36,000 lives every year, Bayer noted.