Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals Inc. selected Nexavar (sorafenib tosylate) tablets as the global trade name for sorafenib, the oral investigational drug under FDA review for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer.
Bayer and Onyx filed a new drug application (NDA) in July 2005 requesting approval in advanced renal cell cancer by the US Food and Drug Administration. Subsequently, the FDA granted the Nexavar filing priority review status, which means the FDA intends to make a determination within six months of when they received the NDA. Additionally in September 2005, a marketing authorisation application (MAA) was submitted to the European Medicines Agency (EMEA) to market Nexavar in Europe. If approved, Nexavar will be marketed by Bayer and Onyx through a co-promotion and co-development agreement, claims a company release.
Nexavar (sorafenib tosylate) tablets, a novel investigational agent, are the first oral multi-kinase inhibitor that targets kinases in both the tumour cell and its vasculature. In preclinical models, Nexavar blocked kinases known to be involved in proliferation (tumour growth) and angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ß, KIT, FLT-3, and RET.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.