Bayer has picked up marketing authorisation for its second-line systemic treatment for liver cancer in the EU.
Stivarga is the first and only treatment that has demonstrated a significant improvement in overall survival (OS) in second-line HCC.
This marks the third major approval in five months for Stivarga, with the product also gaining approval in the US and Japan in April and June, respectively.
The European Commission approval is based on data from the Phase III RESORCE study, in which Stivarga demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar.
Nexavar is the only approved first-line treatment and Stivarga the only approved second-line therapy in Europe and the US for patients with HCC.
Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer, said: “Liver cancer is often diagnosed late and difficult to treat, but the EU approval of Stivarga for HCC marks the first treatment advance for patients in nearly a decade.”
Liver cancer is often more difficult to treat than other cancers with an annual mortality rate of 48,000 in the EU. Globally, it is the second leading cause of cancer-related deaths.
Additional regulatory filings for Stivarga in HCC are under review in other countries around the world, including China.