Link : Regorafenib from Bayer Submitted to Health Authorities Seeking Approval in Second-Line Treatment of Liver Cancer .
Regulatory submissions in the U.S., Japan and Europe were completed based on data from the Phase III RESORCE study, in which regorafenib demonstrated statistically significant improvement in overall survival .
Currently there are no approved therapies for the treatment of unresectable hepatocellular carcinoma (HCC) in the second-line setting .
Leverkusen, Germany, November 7, 2016 –
Bayer today announced the submission of applications to extend the marketing authorization for its oral multi-kinase inhibitor regorafenib in the U.S., Japan and Europe, for the second line treatment of patients with unresectable hepatocellular carcinoma (HCC). Regorafenib is already approved under the brand name Stivarga® in many countries to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumors.