CHMP backs Bayer Schering's Nexavar

Berlin, Germany-based Bayer Schering Pharma, part of the Bayer group, has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the use of its drug Nexavar (sorafenib) in the treatment of hepatocellular carcinoma.

Nexavar, for which analysts forecast peak sales in the region of $500.0 million in the liver cancer indication, was granted US Food and Drug Administration priority review in August (Marketletters passim), and BSP says it anticipates a final ruling from the European Commission during October. The drug is in-licensed from USA-based Onyx Pharmaceuticals, whose shares rose 3.4% to $42.24 in New York trading on September 21.

Philip Johnson, professor of oncology at the University of Birmingham, UK, commented: "for the thousands of patients with advanced HCC there are currently no licensed therapies in the UK or Europe that significantly improve survival."