FDA approves Eisai and Merck’s Lenvima for first-line treatment of liver cancer

In a significant development for cancer treatment, Eisai and Merck have announced that the U.S. Food and Drug Administration (FDA) has approved Lenvima (lenvatinib) for the first-line treatment of hepatocellular carcinoma (HCC), the most common type of primary liver cancer in adults. This approval marks a pivotal advance, offering a new treatment option for patients with unresectable HCC, a condition where the cancer cannot be removed by surgery.

Lenvima’s FDA approval was propelled by the outcomes of the Phase 3 REFLECT study, which demonstrated that Lenvima significantly outperformed sorafenib, previously a standard treatment, in various critical measures such as overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). These results signify a major step forward in the management of hepatocellular carcinoma, providing hope for better patient outcomes.

Dr. Ghassan Abou-Alfa, a medical oncologist at Memorial Sloan Kettering Cancer Center, emphasized the impact of this approval: “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.”

Developed by Eisai, Lenvima is a kinase inhibitor that targets vascular endothelial growth factor (VEGF) receptors, which are involved in pathogenic angiogenesis, tumor growth, and cancer progression. This action helps to block the blood supply that tumors need to grow, offering a mechanism of action that disrupts cancer progression.

In March 2018, Eisai and Merck entered a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima. This partnership extends to exploring Lenvima as a monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab).

Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, stated: “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.”

Since its first U.S. FDA approval in February 2015 for differentiated thyroid cancer, Lenvima has received subsequent approvals for conditions such as advanced renal cell carcinoma in combination with everolimus. The latest approval for HCC highlights Lenvima’s growing role in cancer therapy across multiple tumor types.