Bayer and Onyx receive European approval for Nexavar

Bayer Healthcare and Onyx Pharmaceuticals have announced that their Nexavar tablets for the treatment of patients with heptacellular carcinoma (HCC) have received marketing authorisation from the European commission.

The decision sees Nexavar become the first and only approved systemic drug therapy for liver cancer and the only therapy shown to improve overall survival rates.

Arthur J Higgins, chairman of the executive committee of Bayer, confirmed that Nexavar’s approval was an “unprecedented advance” for patients with HCC who previously had no approved systemic treatment options.

“This milestone will likely establish Nexavar as the standard of care in HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible,” he added.

The European commission’s decision comes off the back of positive data for Nexavar following a Phase III trial demonstrating that Nexavar extended overall survival by 44 percent in patients with HCC compared to those taking a placebo.

Nexavar is currently approved in over 60 countries for treatment of patients with advanced kidney cancer with regulatory findings for the drug’s treatment in liver cancer currently under review in the US and Japan.

Earlier this month, Bayer and Genzyme Corporation announced that MabCampath had received a positive opinion from the European Committee for Medicinal Products for Human Use.