Eisai And Merck Announce FDA Approval Of Lenvima Capsules - Quick Facts

(RTTNews) - Eisai Inc. (ESALY.PK) and Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration approved the kinase inhibitor Lenvima, or lenvatinib, for the first-line treatment of patients with unresectable hepatocellular carcinoma or HCC.

This approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival or OS by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) when compared with sorafenib in patients with previously untreated unresectable HCC.

Dr. Ghassan Abou-Alfa, medical oncologist of Memorial Sloan Kettering Cancer Center said, "REFLECT is the first-ever positive Phase 3 trial against an active comparator in unresectable HCC. The efficacy and safety data from REFLECT are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it."

Eisai and Merck noted that REFLECT showed Lenvima achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with sorafenib.

Adverse reactions, some of which can be serious or fatal, may occur with Lenvima, including hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or impairment, proteinuria, among others. Based on the severity of the adverse reaction, Lenvima should be monitored, withheld or discontinued.