CHMP recommends Advanced Accelerator's Lutathera for GEP-NETs

EMA's CHMP recommended approval of 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).

The company also resubmitted an NDA to FDA for Lutathera. FDA issued a complete response letter for the candidate last December. Advanced Accelerator had said the letter did not ask for additional trials, but raised issues with existing clinical data sets, requested subgroup analyses and a safety update, as well as asked the company to resolve manufacturing concerns (see BioCentury, Jan. 2)...