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FDA Accepts Resubmission of Lutathera NDA for GEP-NETs

Jason M. Broderick @jasoncology
Published: Monday, Aug 28, 2017

The FDA has accepted a resubmitted new drug application (NDA) for Lutathera (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.

In July 2017, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of Lutathera for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive GEP-NETs.
Strosberg JR, Wolin EM, Chasen B, et al. NETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. J Clin Oncol. 2016;34 (suppl; abstr 4005).

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