ARTICLE | Clinical News

Eisai submits sNDA/MAA for Lenvima in first-line HCC

August 10, 2017 10:59 PM UTC

Eisai Co. Ltd. (Tokyo:4523) submitted an sNDA to FDA and an MAA to EMA to expand the label for Lenvima lenvatinib mesylate (E7080) to include first-line treatment of hepatocellular carcinoma (HCC). The MAA is indicated to treat unresectable HCC. In June, Eisai submitted a regulatory application in Japan to treat HCC, and plans to submit an application in China "within the latter half of fiscal 2017" ending March 31, 2018...