ARTICLE | Company News

Advanced Accelerator resubmits NDA for neuroendocrine tumor candidate

July 27, 2017 9:44 PM UTC

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said Thursday it resubmitted an NDA for Lutathera (177-Lu-Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

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, and asked the company to resolve manufacturing concerns (see BioCentury Extra, Dec. 21, 2016). ...