Posted by Michael Wonder on 26 May 2018
Eisai and Merck provide update on supplemental new drug application for lenvatinib in first-line unresectable hepatocellular carcinoma
24 May 2018 - Eisai and Merck announced today that the U.S. FDA has extended the action date for the supplemental new drug application for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma.
The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application.
The agency expects to complete the review on or before 24 August 2018, thus extending the target action date by a standard extension period of three months from the original PDUFA action date of 24 May 2018.
