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Lutetium Lu 177 Dotatate Approved for GEP-NETS

The FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc.) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Approval was based on data from NETTER-1, a randomized, multicenter, open-label, active-controlled trial in 229 patients with progressive, well-differentiated, locally advanced/inoperable or metastatic somatostatin receptor-positive midgut carcinoid tumors. Patients were randomly assigned (1:1) to either lutetium Lu 177 dotatate with long-acting octreotide or high-dose long-acting octreotide.

The primary end point was progression-free survival determined by a blinded independent radiology committee using RECIST 1.1. The median progression-free survival was not reached in the lutetium Lu 177 dotatate arm and was 8.5 months in the high-dose long-acting octreotide arm (HR 0.21; 95% CI: 0.13-0.32; P<0.0001).

For More Information

Strosberg JR, Wolin EM, Chasen B, et al (2016). NETTER-1 phase III: efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. J Clin Oncol, 34 (suppl). Abstract 4005.

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