BioCentury
ARTICLE | Clinical News

EC approves Lutathera for GEP-NETs

October 6, 2017 3:20 PM UTC

The European Commission approved Lutathera (177-Lu-Dotatate, 177Lu-DOTA0-Tyr3-Octreotate, Lutetium Lu 177 Dotatate) from Advanced Accelerator Applications S.A. (NASDAQ:AAAP) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Specifically, the approval is for unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive GEP-NETs in adults.

A resubmitted NDA for Lutathera to treat GEP-NETs in adults is under FDA review with a Jan. 26 PDUFA date (see BioCentury, Sept. 1)...