The Nexavar approval is specifically for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon- alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar will be commercialized in Europe by Bayer.
The European approval was based on phase III data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell carcinoma. In the study, Nexavar doubled progression- free survival in previously treated patients when compared to placebo.
“For more than a decade, Europeans with kidney cancer have not had a new approved treatment. We are pleased to play a part in addressing this unmet medical need,” said Dr Gunnar Riemann, head of Bayer HealthCare’s pharmaceuticals division.
Nexavar was approved by the FDA in December 2005 and has since been approved in Switzerland, Mexico, Chile, Brazil, Korea, and Argentina. Regulatory filings have been completed in several countries, including Australia, Canada, Turkey, and Japan.