Eisai submits marketing authorisation for lenvatinib

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Eisai has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the first-line use of lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC). 

The EMA submission is based on results of the pivotal Phase III REFLECT study (Study 304). Lenvatinib was the only first-line agent to demonstrate non-inferior overall survival (OS) versus sorafenib in uHCC, with a significant and clinically meaningful improvement versus sorafenib in all secondary efficacy endpoints of progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).

Patients with hepatocellular carcinoma face a poor prognosis, with a complex disease which accounts for approximately 90% of liver cancer cases worldwide.

Professor Jeff Evans, Professor of Translational Cancer Research, University of Glasgow, said: “There is a significant unmet need for patients with this advanced form of liver cancer, where treatment options are limited.”

Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai, said: “This announcement represents another important milestone for lenvatinib in difficult-to-treat cancer types.”

Lenvatinib is currently approved in the EU for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma refractory to radioactive iodine. It is also approved in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy.