Nexavar (sorafenib) tablet has been granted orphan medicinal product status for the treatment of hepatocellular carcinoma (HCC), or liver cancer, by the European Commission. This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA), Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced here.

"This orphan medicinal product designation demonstrates the European Commission's commitment to the study and development of treatments for rare diseases," Susan Kelley, vice president, Oncology, Bayer Pharmaceuticals Corporation said adding, "This support adds momentum to our research efforts with Nexavar and brings hope of a new treatment option to liver cancer patients in Europe."

At the 16th American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR- NCI-EORTC) meeting in 2004, investigators reported that in a Phase II single agent study, 43 percent of patients treated with Nexavar experienced stable disease for at least four months and an additional nine percent of patients experienced tumour shrinkage. The most common grade 3/4 drug-related toxicities were fatigue (9.5 percent), diarrhoea (8 percent), and hand-foot skin reaction (5 percent). The toxicity profile of Nexavar was similar to previously reported safety analysis in patients with renal cell carcinoma.

Nexavar received approval from the US FDA in December 2005 to treat patients with advanced renal cell carcinoma (RCC), or kidney cancer. The European Commission has also granted Nexavar an orphan medicinal product designation for kidney cancer and a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) in September 2005 for approval to market Nexavar within the European Union for kidney cancer.

Nexavar is the first oral multi-kinase inhibitor that targets both the tumour cell and tumour vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR- 2, VEGFR-3, PDGFR-B, KIT, and FLT-3.