The positive opinion is for Nexavar (sorafenib) 200mg film-coated tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
This positive Committee for Medicinal Products for Human Use (CHMP) opinion will be elevated to the European Commission where a positive ruling could lead to marketing authorization for all countries in the European Union in the second half of 2006.
The companies also announced the approval of Nexavar (sorafenib) tablets by the Mexican Ministry of Health for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer.
Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in the EU as well as in Mexico.
Nexavar was approved by the FDA in December 2005 and in March 2006 in Switzerland. In addition, Bayer has completed filings in several countries, including Australia, Brazil, Canada, and Turkey.