Eisai and Merck said the European Commission granted a marketing authorization for the oral receptor tyrosine kinase inhibitor Lenvima (lenvatinib), as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.
Lenvima is the first new, first-line treatment for advanced or unresectable HCC in a decade to show an overall survival treatment effect by statistical confirmation of non-inferiority against standard of care.
Lenvima is marketed in Japan for the treatment of HCC and in the United States for the treatment of first-line unresectable HCC, and applications seeking approval for this indication have been submitted to additional countries.
