4 January 2017 - Bayer today announced that the U.S. FDA has granted priority review designation to the supplemental new drug application for regorafenib monohydrate for the second-line treatment of patients with unresectable hepatocellular carcinoma in the U.S.
Regorafenib monohydrate has also been submitted to regulatory authorities in Japan and the EU for the treatment of second-line hepatocellular carcinoma and submissions in additional countries are in progress.