23 August 2018 - Eisai and Merck announced today that the European Commission has granted a marketing authorisation for the oral receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy. 

This is the first new first-line treatment option for advanced or unresectable hepatocellular carcinoma (HCC) to be approved in Europe in approximately 10 years.

This approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.

Read Eisai press release