publication date: Feb. 2, 2018
Drugs and Targets FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS
FDA has approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Approval was based on data from NETTER-1 (NCT01578239), 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 randomized (1:1) to receive either lutetium Lu 177 dotatate (7.4 GBq [200 mCi] every 8 weeks for up to 4 administrations; maximum cumulative dose of 29.6 GBq) with long-acting octreotide (30 mg by intramuscular injection every 4 weeks) or high-dose long-acting octreotide (60 mg by intramuscular injection every 4 weeks).
Lutetium Lu 177 dotatate was co-administered with an amino acid solution as a renal protectant. In the US, patients enrolled in NETTER-1 received Aminosyn II 10%, a commercially available solution of amino acids.
The major efficacy outcome measure was progression free survival determined by a blinded independent radiology committee using RECIST 1.1. The median PFS was not reached for lutetium Lu 177 dotatate and was 8.5 months in the high-dose long-acting octreotide arm (hazard ratio 0.21; 95% CI: 0.13, 0.32; p<0.0001).
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