The FDA has accepted the new drug application and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act target action date is Dec. 28, 2016.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
The Lutathera NDA is based on the results of a randomized pivotal phase III study, NETTER-1, that compared treatment using Lutathera with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under Octreotide LAR treatment and overexpressing somatostatin receptors. The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79 percent in disease progression or death versus a treatment with a double dose of Octreotide LAR. Efficacy and safety data from a large phase I-II trial conducted in more than 1,200 patients in NET indications is also part of the NDA.