Bayer HealthCare Pharmaceuticals and
said Friday that the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Nexavar for liver cancer, recommending that European Union health regulators give marketing authorization to the drug.
The CHMP positive opinion was based on phase III data from the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial in which Nexavar extended overall survival by 44% over the placebo in patients with liver cancer. Nexavar is already approved for kidney cancer in Europe and the U.S.
Onyx shares rose 64 cents, or 1.6%, to $41.52, while Bayer was recently 18 cents, or 0.2% lower at $80.97.