FDAnews Drug Daily Bulletin

EC GRANTS ORPHAN STATUS TO NEXAVAR

April 27, 2006
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The European Commission (EC) granted orphan medicinal product status to Nexavar (sorafenib) tablets for treating hepatocellular carcinoma (HCC), or liver cancer, according to drugmakers Bayer Pharmaceuticals and Onyx.

Clinical trial results of a Phase II single-agent study indicate that 43 percent of subjects treated with Nexavar experienced stable disease for at least four months and nine percent of subjects' tumors shrank.

A Phase III trial designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of the drug versus placebo is ongoing.

"Patients diagnosed with liver cancer have a poor prognosis due to the aggressive nature of the disease," said Jordi Bruix, coprimary investigator of the Phase III trial, and head of the Barcelona Clinic Liver Cancer Group at the University of Barcelona, Spain. "The global medical community recognizes 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."