EISAI AND MERCK & CO., INC., KENILWORTH, N.J., U.S.A. ANNOUNCE FDA APPROVAL OF LENVIMA? (LENVATINIB) CAPSULES FOR FIRST-LINE TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
TOKYO August 17, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA??(lenvatinib mesylate) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). This approval was based on results from REFLECT (Study 304), where LENVIMA demonstrated a proven treatment effect on overall survival (OS) *1?by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) *2?and objective response rate (ORR) *3?when compared with sorafenib in patients with previously untreated unresectable HCC. This is the second approval of LENVIMA for use in the treatment of HCC following approval in Japan earlier this year, and the first new systemic therapy to be approved in the U.S. for the first-line treatment of unresectable HCC in approximately 10 years.