The European Commission (EC) has granted a marketing authorisation for the oral receptor tyrosine kinase (RTK) inhibitor, LENVIMA (lenvatinib mesylate), as first-line treatment for adults with advanced or unresectable hepatocellular carcinoma (HCC).
approval
This approval, granted to Eisai and MSD (known as Merck & Co in the US and Canada), has been based on the results from the REFLECT study where LENVIMA demonstrated a treatment effect on overall survival by statistical confirmation of non-inferiority to sorafenib.
Additionally, it showed 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.
HCC accounts for 85–90% of all liver cancer cases and treatment options for unresectable HCC are limited and the prognosis is poor, making this an area of high unmet medical need.
“Patients with hepatocellular carcinoma are faced with a cancer that is difficult to treat and has a particularly poor prognosis, with only one systemic first-line treatment option currently available,” said Gary Hendler, chairman and CEO, Eisai EMEA. “LENVIMA is the first new treatment option to be made available in this first-line systemic treatment setting in over a decade and represents an important new therapeutic option for patients. Eisai and Merck are therefore committed to working together to ensure that patients have rapid access to LENVIMA across Europe.”
“Today’s approval brings an important new first-line treatment option to patients with hepatocellular carcinoma in Europe,” commented Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “As a result of our efforts with Eisai on LENVIMA, we continue to make significant progress in gaining regulatory approval in countries around the world, as we strive together to make this medicine available to patients in need as quickly as possible.”