FDA approves LENVIMA® for unresectable hepatocellular carcinoma

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Eisai Inc. and Merck, known as MSD outside of the United States and Canada, have announced that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA ® (lenvatinib) 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) 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.

REFLECT showed that 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. The OS analysis was conducted when 351 events had occurred in the LENVIMA arm and 350 events had occurred in the sorafenib arm, as prespecified in the statistical analysis plan.

Dr. Ghassan Abou-Alfa , medical oncologist, Memorial Sloan Kettering Cancer Center said, “unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade. 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.”

Shaji Procida, President and Chief Operating Officer, Eisai Inc. said,”Eisai strives to be a leading global R&D-based pharmaceutical company, driven by our human health care mission to improve the lives of patients and their loved ones. That purpose is what has propelled us toward this win for patients with unresectable hepatocellular carcinoma. Our goal is to bring monumental solutions to patients and health care providers, changing expectations for the oncology landscape.”

Dr. Roy Baynes , Senior Vice President and Head of Global Clinical Development , Chief Medical Officer, Merck Research Laboratories said, “We are pleased by the FDA approval of LENVIMA as it marks an important advancement in the treatment of unresectable hepatocellular carcinoma. With our shared mission to find solutions for difficult-to-treat cancers, we look forward to working with Eisai to help bring this needed option to patients and physicians.”