Orphan designation granted to Nexavar by the EC

The European Commission (EC) has granted orphan status to Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) tablets for the treatment of liver cancer following a recommendation from the European Medicines Agency (EMEA).

A Phase II single agent study showed 43% of patients treated with Nexavar experienced stable disease for at least four months and an additional 9% of patients experienced tumour shrinkage. A Phase III trial of Nexavar administered as a single agent is ongoing.

"Patients diagnosed with liver cancer have a poor prognosis due to the aggressive nature of the disease," said Dr Jordi Bruix, head of the Barcelona Clinic Liver Cancer Group, University of Barcelona, Spain. "The global medical community recognises the need for new treatment therapies in liver cancer and I am encouraged by the study data we have seen so far in this patient population." Dr Bruix is co-primary investigator along with Dr Josep Llovet, senior scientist, at the Liver Disease Division, Mount Sinai School of Medicine in New York.

Nexavar received approval from the US FDA in 2005 to treat patients with advanced renal cell carcinoma, or kidney cancer. The EC has also granted Nexavar an orphan designation for kidney cancer and a Marketing Authorisation Application had been submitted to the EMEA to market Nexavar in the European Union for kidney cancer.