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US FDA extends review for Eisai, Merck & Co. liver cancer drug

Eisai Inc. and Merck & Co. Inc. said the U.S. Food and Drug Administration extended its review of Lenvima as a treatment for a type of liver cancer by three months.

The companies filed a supplemental new drug application, or sNDA, for Lenvima as potential first-line treatment for hepatocellular carcinoma that is unresectable, or cannot be removed through surgery.

The Prescription Drug User Fee Act date, also called the target action date or the deadline for the FDA to approve the drug, has been moved to Aug. 24 from May 24. The extension will give the agency additional time to review the application.

Tokyo's Eisai Co. Ltd. is developing the drug, also known as lenvatinib, with New Jersey-based Merck & Co. under a global collaboration. The drug is already approved to treat differentiated thyroid cancer and renal cell cancer.