Tokyo, June 29, 2006 (JCN) - Today, Bayer Yakuhin Ltd. submitted a marketing application of an orally available anti-cancer drug, Nexavar(R) (sorafenib, BAY 43-9006) 200 mg tablet for the treatment of Advanced Renal Cell Carcinoma (RCC), which was developed by Bayer HealthCare AG (Germany) and Onyx Pharmaceuticals, Inc. (USA), to the Pharmaceuticals and Medical Devises Agency (PMDA) in Japan. Nexavar(R) was approved by FDA in December 2005 for the first time in the world and is now on the US market. Also it was approved by the regulatory authorities of Switzerland, Mexico, Chile, Brazil and South Korea. In EU, the application was submitted to EMEA in September 2005.
