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).
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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