More good news for Bayer and partner Onyx Pharmaceuticals has come with the news that advisors to European regulators are recommending approval for Nexavar as a treatment for liver cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for Nexavar (sorafenib) in the treatment of hepatocellular carcinoma, the most common form of liver cancer. The recommendation is based on positive data from the Phase III SHARP trial which demonstrated that the drug extended overall survival by 44% in patients with HCC versus placebo and the study revealed no significant differences in serious adverse event rates between Nexavar and placebo-treated groups.
The European recommendation “underscores the potential of Nexavar to become the standard systemic drug therapy for the treatment of liver cancer," said Gunnar Riemann, a member of Bayer HealthCare's executive committee. It comes after the US Food and Drug Administration granted a priority review to the drug, which is currently approved in more than 50 countries to treat advanced kidney cancer.