Bayer/Onyx' Nexavar granted US and EU orphan status for liver cancer

Germany's Bayer and USA-based Onyx Pharmaceuticals say that their co-developed anticancer drug Nexavar (sorafenib) tablets have been granted Orphan Drug status for the treatment of hepatocellular carcinoma, or liver cancer, by the US Food and Drug Administration and a similar designation has been granted by the European Commission. The firms noted that a Phase III trial of the oral multi-kinase inhibitor administered as a single agent is ongoing. It is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of Nexavar versus placebo in liver cancer patients. Also, a randomized Phase II evaluation in liver cancer in combination with the chemotherapeutic agent doxorubicin is ongoing.