Nexavar approved by EC as advanced kidney cancer therapy

European marketing authorisation has been granted to Nexavar (sorafenib) tablets for patients with kidney cancer and who have failed prior interferon-alpha or interleukin-2 based therapy.

Nexavar, developed by Onyx Pharmaceuticals of California, US in collaboration with Bayer, was approved by the US Food and Drug Administration (FDA) in December 2005 and has since been approved in Switzerland, Mexico, Chile, Brazil, and Korea. Regulatory filings have been completed in several countries, including Australia, Canada, Turkey, and Japan. Bayer will now commercialise Nexavar in Europe.

"Nexavar delays the progression of kidney cancer and is generally well tolerated," said Dr Escudier, head of Immunotherapy and Innovative Therapy Unit at the Gustave-Roussy Institute in Paris, France, and co-principal investigator of the pivotal study that led to the approval of Nexavar by the European Commission.

In preclinical models, the oral multi-kinase inhibitor targeted members of two classes of kinases known to be involved in both cell proliferation and blood supply, both processes that enable cancer growth.

The drug is being studied in a variety of cancers and is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A Phase III clinical trial in non-small cell lung cancer (NSCLC) for first-line patients was initiated in February 2006.