FDA accepts NDA for Advanced Accelerator's Lutathera

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA accepted for review a resubmitted NDA for Lutathera (177-Lu-Dotatate, 177Lu-DOTA0-Tyr3-Octreotate, Lutetium Lu 177 Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The PDUFA date is Jan. 26, 2018.

FDA issued a complete response letter for the candidate last December. Advanced Accelerator had said the letter did not ask for additional trials, but requested subgroup and safety analyses, and asked the company to resolve manufacturing concerns (see BioCentury, Dec. 27, 2016)...