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OncologyFDA Approved

Lutetium-177 dotatate (Lutathera)

Intravenous
Written by Peptide Association Editorial TeamMedically reviewed by Ian Justl Ellis, MD, CPTLast reviewed Editorial policy

Overview

A radiolabeled somatostatin analog consisting of the peptide DOTA-Tyr3-octreotate chelated to the beta-emitting radioisotope lutetium-177. Lutathera binds with high affinity to somatostatin receptor subtype 2 (SSTR2), which is overexpressed on neuroendocrine tumor cells, delivering targeted radiation therapy directly to tumor cells while sparing surrounding normal tissue.

Mechanism of Action

This peptide receptor radionuclide therapy (PRRT) approach combines receptor-targeted delivery with cytotoxic radiation.

Research Summary & Key Findings

FDA-approved in 2018 for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). NETTER-1 trial showed 79% reduction in risk of disease progression or death vs. high-dose octreotide (Strosberg et al., NEJM, 2017). Overall response rate of 18% with disease control rate of 82%. Nephrotoxicity and myelosuppression are principal dose-limiting toxicities.

Clinical Status

FDA Approved

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.

Administration Routes

Intravenous

References

Primary literature

Study-level citations for this compound are being verified against the primary sources before publication. The database queries above return the current indexed literature in the meantime.

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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.