- Lenvatinib filing based on pivotal Phase III REFLECT study demonstrating non-inferior overall survival compared to sorafenib
- Simultaneous submissions to EMA and US FDA follow filing with Japan’s MHLW in June 2017
Hatfield UK, July 26, 2017— Eisai announced it 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). Patients with hepatocellular carcinoma face a poor prognosis, with a complex disease which accounts for approximately 90% of liver cancer cases worldwide.
“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.”
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). The REFLECT study results were presented in an oral session at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and will be published soon in the peer-reviewed journal The Lancet.
“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.”
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 (DTC) refractory to radioactive iodine (RAI). Lenvatinib 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.
Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai’s human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.