*.- Positive opinion based on data from the Phase III RESORCE study, in which regorafenib demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib) .*.- Approval could provide first treatment advance in nearly a decade .
*.- Final decision from the European Commission anticipated within the next two months .
BERLIN, Germany // June 23, 2017 .
Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended regorafenib for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). Regorafenib is the first and only treatment that has demonstrated a significant improvement in overall survival in second-line HCC patients who previously had no other options. The final decision of the European Commission on the marketing authorization is expected in the coming months. The anti-cancer medication from Bayer is already approved under the brand name Stivarga® in more than 90 countries worldwide for the treatment of metastatic colorectal cancer (CRC), including countries of the EU, and in more than 80 countries globally for the treatment of metastatic gastrointestinal stromal tumors (GIST), including countries of the EU. The product recently gained approval in the U.S. for second-line treatment of HCC and additional regulatory filings for Stivarga in HCC are under review in countries around the world, including China.
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