According to the article published in Pharmalive
Bayer has been granted marketing approval of Nexavar® in Japan for the treatment of advanced renall cell carcinoma (RCC), the most common form of kidney cancer. Nexavar is an oral multi-kinase inhibitor jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. which targets both the tumor cell and tumor vasculature. In Japan, Nexavar is the first approved oral targeted therapy for metastatic RCC.
“This approval of Nexavar is a crucial step for patients with advanced kidney cancer in Japan”, said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This is also a major accomplishment for the company's oncology franchise in Japan.”
The new drug application (NDA) for Nexavar in RCC was filed in June 2006. In September 2007, an additional application for the treatment of hepatocellular carcinoma (HCC) was filed. Japanese authorities recently granted priority review status for Nexavar in this indication.
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