Eisai seeks marketing authorisation for lenvatinib from EMA


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

HCC is a complex disease in which patients face a poor prognosis and accounts for approximately 90% of liver cancer cases worldwide.

Discovered and developed by Eisai, lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.

The EMA filing is based on results of the pivotal international, multicentre, open-label, randomised, non-inferiority Phase III REFLECT trial that has been conducted to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with uHCC.

"This announcement represents another important milestone for lenvatinib in difficult-to-treat cancer types."

Lenvatinib demonstrated 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).

Eisai oncology business group chief commercial officer and Europe, Middle East and Africa (EMEA) chairman and CEO Gary Hendler said: “This announcement represents another important milestone for lenvatinib in difficult-to-treat cancer types.

“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.”

The Eisai treatment is currently approved in the European Union (EU) for adult patients with progressive, locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).

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 (VEGF)-targeted therapy.