Nexavar (sorafenib) tablets will be indicated for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN). Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland.
This approval is the first the drug has received in Europe; it was given approval in the US in December 2005. In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada, and Turkey. Bayer is anticipating blockbuster potential from the drug, with sales reaching over $1 billion a year.
Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) – two important cancer growth activities.
“The approval of Nexavar in Switzerland marks an important step in the brand’s entry into Europe. We are pleased with the decision by Swissmedic, and proud that we can now make this therapy available to physicians and patients in this region,” said Dr Gunnar Riemann, head of Bayer HealthCare’s pharmaceuticals division.