EC GRANTS ORPHAN-DRUG DESIGNATION TO NEXAVAR

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Bayer Pharmaceuticals and Onyx Pharmaceuticals have announced that Nexavar (sorafenib) has been granted orphan-drug status for the treatment of hepatocellular carcinoma by the European Commission (EC). This designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency.

A Phase III trial of Nexavar administered as a single agent is ongoing. The study 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. A randomized Phase II trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is also ongoing.