Eisai, Merck bag Lenvima FDA approval for unresectable HCC

Lenvima FDA appoval : Eisai and Merck announced that the US Food and Drug Administration (FDA) has approved their kinase inhibitor Lenvima (lenvatinib) capsules for first-line treatment of hepatocellular carcinoma (HCC), a common type of primary liver cancer adults.

Lenvima FDA approval, which is for HCC that is unresectable, was driven by results of the phase 3 Reflect study in which the Eisai and Merck liver cancer drug proved to be superior to sorafenib as a first-line treatment in HCC patients.

Lenvima scored over sorafenib for various parameters such as overall survival (OS), clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR).

Commenting on Lenvima FDA approval, 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.”

Eisai, Merck bag Lenvima FDA approval for unresectable HCC

Eisai, Merck announce Lenvima FDA approval for unresectable HCC. Photo courtesy of Eisai Inc.

Discovered and developed by Eisai, Lenvima blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). The cancer drug blocks other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression apart from their normal cellular functions such as fibroblast growth factor (FGF) receptors FGFR1-4.

In March 2018, Eisai and Merck agreed to enter into strategic collaboration for the worldwide co-development and co-commercialization of Lenvima. As per the deal, Eisai and Merck agreed to jointly develop and commercialize Lenvima as monotherapy and also in combination with the latter’s anti-PD-1 therapy, Keytruda (pembrolizumab).

Dr. Roy Baynes – Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at Merck Research Laboratories, commenting on Lenvima FDA approval, 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.”

Lenvima got its first US FDA approval in February 2015 for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). In May 2016, Lenvima bagged another US FDA approval, which was in combination with everolimus, for patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.

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