Posted by Michael Wonder on 08 Aug 2017
Bayer receives EU approval for Stivarga (regorafenib) for the second-line systemic treatment of liver cancer
7 August 2017 - Approval marks first treatment advance in nearly a decade and is based on data from the Phase III RESORCE study, in which Stivarga (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma patients previously treated with Nexavar (sorafenib).
Bayer today announced the European Commission has granted marketing authorization for Stivarga (regorafenib) for the treatment of adult patients with HCC who have been previously treated with Nexavar (sorafenib). Stivarga is the first and only treatment that has demonstrated a significant improvement in overall survival in second-line hepatocellular carcinoma (HCC).
This marks the third major approval in five months for Stivarga, with the product also gaining approval in the U.S. and Japan for second-line treatment of HCC in April and June, respectively.
