According to the company, this positive European Committee for Medicinal Products for Human Use (CHMP) opinion will be elevated to the European Commission where a likely favorable ruling could lead to marketing authorization for European Union member states this year. Nexavar is currently approved in more than 50 countries for the treatment of patients with advanced kidney cancer.
Gunnar Riemann, member of the Bayer HealthCare executive committee said: “The positive opinion issued by the CHMP marks another significant milestone for Nexavar in liver cancer. The committee’s decision underscores the potential of Nexavar to become the standard systemic drug therapy for the treatment of liver cancer.”
Hollings Renton, chairman, president and CEO of Onyx, said: “This decision, coupled with the priority review status granted by the FDA, means that patients in these regions are one step closer to a new treatment for their liver cancer.”