# Lutetium-177 dotatate

Source: https://onco.cc/drugs/lutathera/  
OnCo record `lutathera` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Lutetium-177 dotatate was the first modern radioligand therapy (2018), for neuroendocrine tumours, and is now used in first line.

## Summary

Lutetium-177 dotatate is a radioligand therapy: the somatostatin analogue DOTATATE binds SSTR2 on neuroendocrine tumour cells and carries the beta emitter 177Lu into them, irradiating over a few millimetres. NETTER-1 established it in midgut NETs progressing on octreotide, and NETTER-2 (2024) moved it into first line for higher grade-2 and grade-3 GEP-NETs with PFS 22.8 versus 8.5 months. It was approved in 2018 for SSTR-positive GEP-NETs, with paediatric use from age 12 added in 2024. Dosing is 7.4 GBq every 8 weeks for 4 doses with an amino acid infusion to protect the kidneys; lymphopenia is common, and myelodysplastic syndrome (2.3%) and acute leukaemia (0.5%) are rare late risks. Alpha-emitting successors RYZ101 and AlphaMedix are in phase 3. For a newcomer: the first modern radioligand therapy and the template for a whole class.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Lutathera
- Code: 177Lu-DOTATATE
- Modality: Radioligand therapy (beta)
- Mechanism: SSTR2 agonist peptide with 177Lu.
- Approvals: US 2018: SSTR+ GEP-NETs; US 2024: Paediatric ≥12 years; first-line (NETTER-2 label); EU 2017: First approval globally (Sep 2017)
- Dosing: IV infusion; 7.4 GBq (200 mCi) every 8 weeks for 4 doses, with amino acid infusion starting 30 minutes before and continuing ≥3 hours
- Toxicity (grade 3+): Lymphopenia 44%; GGT increased 20%; Vomiting 7%; Nausea 5%; AST increased 5%; ALT increased 4%; Hyperglycaemia 4%; Hypokalaemia 4%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Lutetium_(177Lu)_oxodotreotide
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lutetium-177%20dotatate

## Connected records

- biomarkers: [Somatostatin receptor expression by PET (SSTR-positive)](https://onco.cc/biomarkers/sstr-pet-expression/)
- cancers: [Cancer of unknown primary, favourable subsets](https://onco.cc/cancers/cup-favourable-subsets/), [Esthesioneuroblastoma (olfactory neuroblastoma)](https://onco.cc/cancers/esthesioneuroblastoma/), [Extrapulmonary neuroendocrine carcinoma](https://onco.cc/cancers/extrapulmonary-nec/), [Grade 3 well-differentiated neuroendocrine tumour](https://onco.cc/cancers/grade-3-net/), [Hereditary pheochromocytoma and paraganglioma (SDHx, VHL, RET, NF1, MAX and TMEM127)](https://onco.cc/cancers/hereditary-ppgl/), [Lung neuroendocrine tumours (typical and atypical carcinoid)](https://onco.cc/cancers/lung-net/), [Metastatic pheochromocytoma and paraganglioma](https://onco.cc/cancers/metastatic-ppgl/), [Multiple endocrine neoplasia syndromes (MEN1, MEN2, MEN4)](https://onco.cc/cancers/multiple-endocrine-neoplasia/), [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://onco.cc/cancers/pancreatic-net/), [Pheochromocytoma and paraganglioma (PPGL)](https://onco.cc/cancers/pheochromocytoma-paraganglioma/), [Pituitary tumours (pituitary neuroendocrine tumours) and pituitary carcinoma](https://onco.cc/cancers/pituitary-tumours/), [Small intestinal neuroendocrine tumours](https://onco.cc/cancers/small-intestinal-net/)
- technologies: [Lutetium-177 radioligand therapy](https://onco.cc/technologies/lu177-radioligand-therapy/), [Peptide receptor radionuclide therapy (PRRT)](https://onco.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/), [Radiopharmaceutical GMP and releasing a drug that decays](https://onco.cc/technologies/radiopharmaceutical-gmp-release/), [Research reactors for medical isotopes (Mo-99, Lu-177, I-131)](https://onco.cc/technologies/research-reactor-isotope-production/), [Somatostatin receptor PET (68Ga/64Cu-DOTATATE)](https://onco.cc/technologies/sstr-pet/)
- targets: [Somatostatin receptor 2](https://onco.cc/targets/sstr2/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- terms: [PRRT (peptide receptor radionuclide therapy)](https://onco.cc/terms/prrt-term/), [SDH deficiency (SDHB immunohistochemistry loss)](https://onco.cc/terms/sdh-deficiency/)
- trials: [A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab](https://onco.cc/trials/nct05142696/), [ACTION-1](https://onco.cc/trials/action-1/), [NETTER-1](https://onco.cc/trials/netter-1/), [Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs](https://onco.cc/trials/nct04711135/), [Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET](https://onco.cc/trials/nct03972488/)
- pairings: [Beta PRRT → alpha PRRT](https://onco.cc/pairings/prrt-then-alpha-net/), [Beta radioligand → alpha radioligand](https://onco.cc/pairings/beta-then-alpha/), [SSTR PET → PRRT](https://onco.cc/pairings/sstr-pet-to-prrt/)
- ideas: [Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier](https://onco.cc/ideas/idea-reg-yb176-enrichment-capacity/), [Dosimetry-personalised PRRT instead of four fixed cycles](https://onco.cc/ideas/idea-net-dosimetry-prrt/), [Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes](https://onco.cc/ideas/idea-reg-regional-radiopharmacy-hubs/)
- drugs: [131I-MIBG (iobenguane I-131) therapy](https://onco.cc/drugs/i131-mibg/)
- roadmaps: [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://onco.cc/roadmaps/radiopharma-roadmap/)
- people: [Emily K. Bergsland](https://onco.cc/people/emily-bergsland/), [Jonathan R. Strosberg](https://onco.cc/people/jonathan-strosberg/), [Ken Herrmann](https://onco.cc/people/ken-herrmann/), [Simron Singh](https://onco.cc/people/simron-singh/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- key papers: [NETTER-2: lutetium-177 dotatate as first treatment for higher-grade gastroenteropancreatic neuroendocrine tumours](https://onco.cc/key-papers/paper-netter-2-lancet-2024/)
- institutions: [Chulabhorn Hospital / Chulabhorn Royal Academy](https://onco.cc/institutions/chulabhorn-hospital/), [Erasmus MC Cancer Institute](https://onco.cc/institutions/erasmus-mc/), [European Association of Nuclear Medicine](https://onco.cc/institutions/eanm/), [Holden Comprehensive Cancer Center, University of Iowa](https://onco.cc/institutions/iowa-holden/), [Inselspital, Bern University Hospital / University Cancer Center Inselspital](https://onco.cc/institutions/inselspital-bern/), [IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)](https://onco.cc/institutions/irst-meldola/), [Postgraduate Institute of Medical Education and Research, Chandigarh](https://onco.cc/institutions/pgimer-chandigarh/), [Society of Nuclear Medicine and Molecular Imaging](https://onco.cc/institutions/snmmi/), [TUM Klinikum rechts der Isar / CCC München](https://onco.cc/institutions/tum-munich/), [Uppsala University Hospital / Uppsala University](https://onco.cc/institutions/uppsala-akademiska/), [West German Cancer Center (WTZ), University Hospital Essen](https://onco.cc/institutions/essen-wtz/)

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