Lutathera Approved for Gastroenteropancreatic Neuroendocrine Tumors

Advanced Accelerator Applications S.A. announced that the Food and Drug Administration (FDA) has approved Lutathera (lutetium Lu 177 dotatate) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. 

Lutathera is a first-in-class peptide receptor radionuclide therapy (PPRT) agent, a type of targeted therapy consisting of a targeting molecule that carries a radioactive component. Following infusion, the targeting molecule binds to a specific receptor on tumor cells that is then internalized into target cells. The radioactive component subsequently destroys the tumor cells from within. 

The FDA approval was supported by data from a Phase 3 randomized study, NETTER-1 (N=229), that evaluated Lutathera plus best standard of care (octreotide LAR 30mg every 4 weeks) vs octreotide LAR 60mg every 4 weeks alone. Study patients had inoperable midgut NETs progressing under standard-dose octreotide LAR and had overexpressing somatostatin receptors. 

The primary endpoint was achieved in the study, with a 79% reduction in the risk of disease progression or death in the Lutathera arm vs the octreotide LAR 60mg arm (hazard ratio [HR] 0.21, 95% CI: 0.13–0.32; P<0.0001). Median progression-free survival was not reached in the Lutathera arm vs 8.5 months in the octreotide LAR arm. Overall survival analysis indicated a 48% reduction in the estimated mortality risk (HR 0.52, 95% CI: 0.32–0.84) vs treatment with octreotide LAR. The objective response rate was greater in the Lutathera arm vs the octreotide LAR arm (13% vs 4%; P<0.0148). 

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Additionally, safety and efficacy data from an international, single-arm, open-label trial in the Netherlands (N=1,214) among patients with somatostatin receptor positive tumors also supported the FDA approval. Complete or partial tumor shrinkage was seen in 16% of a subset of 360 patients with GEP-NETs. 

Regarding safety, the frequency of lymphopenia, increased gamma-glutamyl transferase, vomiting, nausea, elevated AST/ALT, hyperglycemia, and hypokalemia were higher in the Lutathera arm vs the octreotide LAR arm. 

Lutathera injection will be available as single-dose vials containing 370MBq/mL of lutetium Lu 177 dotatate providing a total of 7.4 GBq (200mCi) of radioactivity. 

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