First In 10 Years, But Lenvima's First-Line Liver Label Could Be Challenged Soon

Eisai and Merck won the first US FDA approval in 10 years for a first-line hepatocellular carcinoma treatment with Lenvima, but challengers are on the horizon. The companies' recent partnership and plans for combination therapy with Keytruda may defend the drug's standing in liver cancer.

FDA Approved typed words on a vintage typewriter

The agreement earlier this year between Eisai Co. Ltd. and Merck & Co. Inc. to partner on the continued development and commercialization of Lenvima (lenvatinib mesylate) appears to be a particularly important defensive move for both companies as the kinase inhibitor has won an important new approval in liver cancer.

Eisai and Merck said on Aug. 16 that the FDA cleared Lenvima for first-line treatment of unresectable hepatocellular carcinoma (HCC), marking the first US approval in the front-line HCC setting in a decade, although it probably won't take another decade for additional competitors to emerge in this indication. Until then, Lenvima may be a formidable rival for Bayer AG's and Amgen Inc

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