Onyx/Bayer's Nexavar gains EC Orphan Status

German drugmaker Bayer and USA-based Onyx Pharmaceuticals says their co-developed anticancer agent Nexavar (sorafenib) has been granted Orphan Drug status for the treatment of hepatocellular carcinoma, by the European Commission.

The firms noted that, in a Phase II monotherapy study, 43% of patients treated with Nexavar experienced stable disease for at least four months and an additional 9% saw tumor shrinkage. The most common grade 3/4 drug-related toxicities were fatigue (9.5%), diarrhea (8%), and hand-foot skin reaction (5%), while the drug's toxicity profile was similar to a previously-reported safety analysis in patients with renal cell carcinoma.