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www.fdanews.com/articles/86476-nexavar-moves-forward-in-europe-mexico

NEXAVAR MOVES FORWARD IN EUROPE, MEXICO

May 1, 2006

Bayer and Onyx have received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Nexavar (sorafenib) as well as approval by the Mexican Ministry of Health, according to the companies.

Nexavar is used for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, and has been shown to double progression-free survival, according to the announcement.

If the CHMP's positive opinion is approved by the European Commission (EC) the drug will receive marketing approval in all the European Union in the second half of this year.