BioCentury
ARTICLE | Clinical News

Lenvima lenvatinib mesylate regulatory update

January 25, 2016 8:00 AM UTC

Eisai said it submitted an MAA to EMA and that FDA accepted and granted Priority Review to an sNDA for Lenvima lenvatinib mesylate to treat advanced or metastatic renal cell carcinoma (RCC). The PDUFA date is May 16. Lenvima is under accelerated review in the EU. ...