# Lutetium-177 dotatate

Source: https://nuclide.cc/drugs/lutathera/  
Nuclide record `lutathera` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.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. The first generic is queued behind the patents: on 21 September 2026 FDA tentatively approved Lantheus's ANDA 217060 (Bravnetsa, 10 mCi/mL), finding it bioequivalent to Lutathera (NDA 208700), but withheld final approval because Advanced Accelerator Applications (Novartis) is suing Lantheus over US patent 10,596,276 in the District of Delaware (Civil Action No. 24-00095); final approval waits for the 30-month stay to run out, a court ruling that the patent is invalid or not infringed, or the patent's expiry on 25 January 2039. For a newcomer: the first modern radioligand therapy and the template for a whole class.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-10-04
- 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
- Drugs@FDA: ANDA 217060, Bravnetsa (Lantheus), tentative approval: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217060
- FDA tentative approval letter, ANDA 217060 (21 Sep 2026): https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217060Orig1s000TAltr.pdf

## Connected records

- isotopes: [Indium-111](https://nuclide.cc/isotopes/in-111/), [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Grade 3 well-differentiated neuroendocrine tumour](https://nuclide.cc/indications/grade-3-net/), [Hereditary pheochromocytoma and paraganglioma (SDHx, VHL, RET, NF1, MAX and TMEM127)](https://nuclide.cc/indications/hereditary-ppgl/), [Lung neuroendocrine tumours (typical and atypical carcinoid)](https://nuclide.cc/indications/lung-net/), [Metastatic pheochromocytoma and paraganglioma](https://nuclide.cc/indications/metastatic-ppgl/), [Multiple endocrine neoplasia syndromes (MEN1, MEN2, MEN4)](https://nuclide.cc/indications/multiple-endocrine-neoplasia/), [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://nuclide.cc/indications/pancreatic-net/), [Pheochromocytoma and paraganglioma (PPGL)](https://nuclide.cc/indications/pheochromocytoma-paraganglioma/), [Small intestinal neuroendocrine tumours](https://nuclide.cc/indications/small-intestinal-net/)
- technologies: [Lutetium-177 radioligand therapy](https://nuclide.cc/technologies/lu177-radioligand-therapy/), [Peptide receptor radionuclide therapy (PRRT)](https://nuclide.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://nuclide.cc/technologies/radioligand-therapy/), [Radiopharmaceutical GMP and releasing a drug that decays](https://nuclide.cc/technologies/radiopharmaceutical-gmp-release/), [Research reactors for medical isotopes (Mo-99, Lu-177, I-131)](https://nuclide.cc/technologies/research-reactor-isotope-production/), [Somatostatin receptor PET (68Ga/64Cu-DOTATATE)](https://nuclide.cc/technologies/sstr-pet/)
- targets: [Somatostatin receptor 2](https://nuclide.cc/targets/sstr2/)
- companies: [Molecular Targeting Technologies](https://nuclide.cc/companies/molecular-targeting-technologies/), [Novartis](https://nuclide.cc/companies/novartis/), [PDRadiopharma](https://nuclide.cc/companies/pdradiopharma/)
- terms: [Fixed versus personalised (dosimetry-guided) dosing](https://nuclide.cc/terms/fixed-versus-personalised-dosing/), [Krenning score](https://nuclide.cc/terms/krenning-score/), [Myelosuppression after radioligand therapy](https://nuclide.cc/terms/myelosuppression-after-rlt/), [Patient release criteria after radioactive treatment](https://nuclide.cc/terms/patient-release-criteria/), [PRRT (peptide receptor radionuclide therapy)](https://nuclide.cc/terms/prrt-term/), [Renal protection with amino acid co-infusion](https://nuclide.cc/terms/renal-protection-amino-acids/), [SDH deficiency (SDHB immunohistochemistry loss)](https://nuclide.cc/terms/sdh-deficiency/), [Theranostic pair](https://nuclide.cc/terms/theranostic-pair-term/)
- trials: [A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab](https://nuclide.cc/trials/nct05142696/), [ACTION-1](https://nuclide.cc/trials/action-1/), [NETTER-1](https://nuclide.cc/trials/netter-1/), [Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs](https://nuclide.cc/trials/nct04711135/), [Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET](https://nuclide.cc/trials/nct03972488/)
- drugs: [Iobenguane I-131 (therapeutic)](https://nuclide.cc/drugs/iobenguane-i-131/), [Lead-212 VMT-alpha-NET](https://nuclide.cc/drugs/pb-212-vmt-alpha-net/), [Lutetium-177 dotatate (radioligand equivalent)](https://nuclide.cc/drugs/lu-177-dotatate-generic/)
- institutions: [Erasmus MC Cancer Institute](https://nuclide.cc/institutions/erasmus-mc/), [European Association of Nuclear Medicine](https://nuclide.cc/institutions/eanm/), [Inselspital, Bern University Hospital / University Cancer Center Inselspital](https://nuclide.cc/institutions/inselspital-bern/), [IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)](https://nuclide.cc/institutions/irst-meldola/), [Society of Nuclear Medicine and Molecular Imaging](https://nuclide.cc/institutions/snmmi/), [TUM Klinikum rechts der Isar / CCC München](https://nuclide.cc/institutions/tum-munich/), [Uppsala University Hospital / Uppsala University](https://nuclide.cc/institutions/uppsala-akademiska/), [West German Cancer Center (WTZ), University Hospital Essen](https://nuclide.cc/institutions/essen-wtz/)
- pairings: [68Ga-DOTATATE PET before Lutathera (177Lu-DOTATATE)](https://nuclide.cc/pairings/ga68-dotatate-then-lutathera/), [Beta PRRT → alpha PRRT](https://nuclide.cc/pairings/prrt-then-alpha-net/), [Beta radioligand → alpha radioligand](https://nuclide.cc/pairings/beta-then-alpha/), [PRRT (177Lu-DOTATATE) with capecitabine and temozolomide (CAPTEM)](https://nuclide.cc/pairings/prrt-plus-captem/), [SSTR PET → PRRT](https://nuclide.cc/pairings/sstr-pet-to-prrt/)
- roadmaps: [Dosimetry roadmap: MIRD schema → fixed dosing → personalised, image-based dose](https://nuclide.cc/roadmaps/dosimetry-roadmap/), [Isotope supply roadmap: reactor dependence → non-uranium production → accelerator-made actinium](https://nuclide.cc/roadmaps/isotope-supply-roadmap/), [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://nuclide.cc/roadmaps/radiopharma-roadmap/), [SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha](https://nuclide.cc/roadmaps/sstr-theranostics-roadmap/)
- ideas: [Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier](https://nuclide.cc/ideas/idea-reg-yb176-enrichment-capacity/), [Dosimetry-personalised PRRT instead of four fixed cycles](https://nuclide.cc/ideas/idea-net-dosimetry-prrt/), [Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes](https://nuclide.cc/ideas/idea-reg-regional-radiopharmacy-hubs/)
- people: [Emily K. Bergsland](https://nuclide.cc/people/emily-bergsland/), [Erik S. Mittra](https://nuclide.cc/people/erik-mittra/), [Jonathan R. Strosberg](https://nuclide.cc/people/jonathan-strosberg/), [Ken Herrmann](https://nuclide.cc/people/ken-herrmann/), [Lisa Bodei](https://nuclide.cc/people/lisa-bodei/), [Simron Singh](https://nuclide.cc/people/simron-singh/)
- bottlenecks: [Clinical trial capacity for radioligand therapy](https://nuclide.cc/bottlenecks/b-rlt-trial-capacity/), [Dosimetry standardisation for radioligand therapy](https://nuclide.cc/bottlenecks/b-dosimetry-standardisation/), [Enriched target material for therapeutic isotopes](https://nuclide.cc/bottlenecks/b-enriched-target-material/), [Hot lab and shielded treatment room capacity](https://nuclide.cc/bottlenecks/b-hot-lab-capacity/), [Manufacturing cost and time for living and radioactive medicines](https://nuclide.cc/bottlenecks/b-manufacturing-cell-therapy/), [Radioactive waste handling and disposal regulation](https://nuclide.cc/bottlenecks/b-radioactive-waste-regulation/), [Reimbursement and coding for radiopharmaceuticals](https://nuclide.cc/bottlenecks/b-reimbursement-coding/)
- key papers: [Health-related quality of life in the NETTER-1 trial of 177Lu-Dotatate](https://nuclide.cc/key-papers/paper-strosberg-netter1-qol-jco-2018/), [NETTER-2: lutetium-177 dotatate as first treatment for higher-grade gastroenteropancreatic neuroendocrine tumours](https://nuclide.cc/key-papers/paper-netter-2-lancet-2024/), [Results and adverse events of personalised peptide receptor radionuclide therapy in 1048 patients with neuroendocrine neoplasms](https://nuclide.cc/key-papers/paper-baum-prrt-1048-patients-oncotarget-2018/)
- fronts: [Radioligand therapy](https://nuclide.cc/fronts/f-radioligand-therapy/)

---
JSON: https://nuclide.cc/api/v1/entities/lutathera.json