Bayer Yakuhin Files Anti-cancer Drug Nexavar(R) for the Treatment of Advanced Renal Cell Carcinoma.
Tokyo, Japan, 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 renal cell carcinoma
Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. (RCC), which was developed by Bayer HealthCare AG (Germany) and Onyx Pharmaceuticals, Inc. (USA), to the Pharmaceuticals and Medical Devises Agency (PMDA PMDA Plastics Machinery Distributors' Association (United Kingdom)
PMDA Plutonium Management and Disposition Agreement (US-Russia)
PMDA Pharmaceuticals and Medical Device Agency (Japan) ) in Japan. Nexavar(R) was approved by FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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 (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. in September 2005.
Nexavar(R) is a drug to suppress cancer growth by stopping the signalling cascade for proliferation of tumor cells and inhibiting angiogenesis which generates vessels to the newly proliferated tumor cells. In ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company 2005, a prolongation of progression-free survival period was presented using the data of global Phase III which more than 900 RCC patients joined. According to that, time to progression or death on placebo group was 84 days, whereas it was 167 days (p<0.000001) on the group treated by Nexavar(R). In ASCO 2006 held in this June, an interim data on the overall survival was presented to show positive results of Nexavar(R).
In Japan, clinical trials of Nexavar(R) for the treatment of RCC started in 2002 and preferable data to support the efficacy and safety of Nexavar(R) was obtained to file today.
Once approved, it will be commercialized as Nexavar(R) in Japan as well. The registration of this product name was already accepted as a trademark in Japan.
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