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Oncology · FDA Approved

Lutetium-177 dotatate (Lutathera)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A radiolabeled somatostatin analog consisting of the peptide DOTA-Tyr3-octreotate chelated to the beta-emitting radioisotope lutetium-177. It binds somatostatin receptors, particularly subtype 2 (SSTR2), which are overexpressed on many neuroendocrine tumor cells, delivering targeted radiation to tumor cells.

This approach is called peptide receptor radionuclide therapy (PRRT).

02 · Research summary & key findings

FDA-approved in 2018 (Lutathera) for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the NETTER-1 trial in progressive midgut neuroendocrine tumors, estimated progression-free survival at 20 months was 65.2% vs. 10.8% with high-dose octreotide, and the response rate was 18% vs. 3% (Strosberg et al., NEJM, 2017) (PMID 28076709). The final analysis showed a median overall survival of 48.0 vs. 36.3 months, a difference that was not statistically significant (PMID 34793718). Severe neutropenia, thrombocytopenia or lymphopenia occurred in under 10% of patients, and 2% developed myelodysplastic syndrome during long-term follow-up (PMID 28076709) (PMID 34793718).

03 · Regulatory status

Lutetium-177 dotatate (Lutathera) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Lutetium-177 dotatate (Lutathera) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Intravenous

References

  1. [1]Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors N Engl J Med, 2017. PMID 28076709
  2. [2](177)Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial Lancet Oncol, 2021. PMID 34793718

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.