Eisai submits marketing authorisation application to EMA for lenvatinib

Global research and development-based pharmaceutical company, Eisai, has submitted a marketing authorization application to the European Medicines Agency (EMA) for its first-line hepatocellular carcinoma treatment, lenvatinib.

The filling has been based on the Phase III REFLECT study, which demonstrated non-inferiority of overall survival with lenvatinib when compared with sorafenib in patients with unresectable hepatocellular carcinoma (uHCC).

“For a decade there has been no advance in the first-line systemic treatment of unresectable hepatocellular carcinoma in Europe,” said Professor Jeff Evans, professor of Translational Cancer Research, University of Glasgow. “There is a significant unmet need for patients with this advanced form of liver cancer, where treatment options are limited.”

“This announcement represents another important milestone for lenvatinib in difficult-to-treat cancer types,” said Gary Hendler, chairman & CEO EMEA, chief commercial officer, Oncology Business Group at Eisai. “Based on the results observed in the REFLECT trial we are looking forward to working with the EMA to bring a much-needed first-line new treatment option for liver cancer patients in Europe one step closer.”