Priority Review for Advanced Accelerator's Lutathera

Advanced Accelerator Applications S. A. (NASDAQ:AAAP) said FDA accepted and granted Priority Review to an NDA for Lutathera (177Lu-DOTA0-Tyr3-octreotate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETS). Its PDUFA date is Dec. 28.

Last September, Advanced Accelerator said Lutathera significantly improved progression-free survival (PFS) compared with a double dose of Sandostatin LAR Depot octreotide acetate in the Phase III NETTER-1 trial to treat midgut neuroendocrine tumors (see BioCentury Extra, Sept. 16, 2015). ...