New indication for Stivarga approved in Europe

German pharma major Bayer (BAYN: DE) got a boost to its shares this morning after it revealed an important additional indication approval for its cancer drug Stivarga (regorafenib) in the European Union.

Bayer today announced the European Commission (EC) has granted marketing authorization for Stivarga for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with the company’s Nexavar (sorafenib). Stivarga is already approved and marketed for the treatment of colorectal cancer and gastrointestinal stromal tumors (GIST).

Regorafenib is the first and only licensed treatment that has demonstrated a significant improvement in overall survival (OS) in second-line HCC, the most-common form of liver cancer. The new approval marks the first licensed treatment advance in nearly a decade and is based on data from the Phase III RESORCE study, in which regorafenib demonstrated significant improvement in overall survival in patients with hepatocellular carcinoma previously treated with sorafenib.