FDA Accepts Resubmission of Lutetium [177Lu] oxodotreotide NDA for GEP-NETs

August 28, 2017 – The FDA has accepted a resubmitted new drug application (NDA) for lutetium [177Lu] oxodotreotide for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before January 26, 2018. The NDA is based on the phase III NETTER-1 trial, which compared lutetium [177Lu] oxodotreotide with high-dose octreotide LAR for … (leggi tutto)