{"entity":{"id":"lutathera","kind":"drug","name":"Lutetium-177 dotatate","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Lutetium_(177Lu)_oxodotreotide","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lutetium-177%20dotatate"}],"tags":[],"related":["sstr-pet-expression"],"cancers":["neuroendocrine","small-intestinal-net","pancreatic-net","grade-3-net","metastatic-ppgl","esthesioneuroblastoma"],"sections":[],"technologies":["radioligand-therapy"],"targets":["sstr2"],"drugs":[],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["prrt-term"],"trials":["netter-1","nct04711135","nct05142696","nct03972488"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lutathera","code":"177Lu-DOTATATE","modality":"Radioligand therapy (beta)","mechanism":"SSTR2 agonist peptide with 177Lu.","approvals":[{"region":"US","year":2018,"indication":"SSTR+ GEP-NETs"},{"region":"US","year":2024,"indication":"Paediatric ≥12 years; first-line (NETTER-2 label)"},{"region":"EU","year":2017,"indication":"First approval globally (Sep 2017)"}],"mechanismSteps":["Radioligand circulates and binds Somatostatin receptor 2 on tumour cells","Ligand is internalised or retained at the membrane","Beta emissions deposit energy within a short range","Clustered DNA double-strand breaks form in the tumour cell and its neighbours (crossfire)","Cells die; unbound ligand is cleared via the kidneys"],"dosing":{"route":"IV infusion","schedule":"7.4 GBq (200 mCi) every 8 weeks for 4 doses, with amino acid infusion starting 30 minutes before and continuing ≥3 hours","modifications":"Hold for grade ≥3 haematologic toxicity or renal toxicity; discontinue after 16-week delay","monitoring":"Blood counts, creatinine, LFTs before each dose; long-term MDS/AML surveillance","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55"},"toxicity":[{"event":"Lymphopenia","grade3PlusPct":44,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"GGT increased","grade3PlusPct":20,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"Vomiting","grade3PlusPct":7,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"Nausea","grade3PlusPct":5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"AST increased","grade3PlusPct":5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"ALT increased","grade3PlusPct":4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"Hyperglycaemia","grade3PlusPct":4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"Hypokalaemia","grade3PlusPct":4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"},{"event":"Myelodysplastic syndrome","anyGradePct":2.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"Median onset 29 months"},{"event":"Acute leukaemia","anyGradePct":0.5,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55","note":"NETTER-1; grade 3-4 rates"}],"access":[{"country":"US","listPrice":"~$47,500 per dose (launch price 2018)","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for unresectable/metastatic GEP-NETs (TA539)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2017-09-26","type":"approval","region":"EU","note":"EMA approval: first modern PRRT","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2018-01-26","type":"approval","region":"US","note":"SSTR+ gastroenteropancreatic NETs (NETTER-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-04-23","type":"approval","region":"US","note":"Paediatric patients ≥12 years","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-06","type":"label-change","region":"US","note":"First-line label based on NETTER-2","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/lutathera/","neighbours":{"biomarker":[{"id":"sstr-pet-expression","kind":"biomarker","name":"Somatostatin receptor expression by PET (SSTR-positive)","route":"/biomarkers/sstr-pet-expression/"}],"cancer":[{"id":"cup-favourable-subsets","kind":"cancer","name":"Cancer of unknown primary, favourable subsets","route":"/cancers/cup-favourable-subsets/"},{"id":"esthesioneuroblastoma","kind":"cancer","name":"Esthesioneuroblastoma (olfactory neuroblastoma)","route":"/cancers/esthesioneuroblastoma/"},{"id":"extrapulmonary-nec","kind":"cancer","name":"Extrapulmonary neuroendocrine carcinoma","route":"/cancers/extrapulmonary-nec/"},{"id":"grade-3-net","kind":"cancer","name":"Grade 3 well-differentiated neuroendocrine tumour","route":"/cancers/grade-3-net/"},{"id":"hereditary-ppgl","kind":"cancer","name":"Hereditary pheochromocytoma and paraganglioma (SDHx, VHL, RET, NF1, MAX and TMEM127)","route":"/cancers/hereditary-ppgl/"},{"id":"lung-net","kind":"cancer","name":"Lung neuroendocrine tumours (typical and atypical carcinoid)","route":"/cancers/lung-net/"},{"id":"metastatic-ppgl","kind":"cancer","name":"Metastatic pheochromocytoma and paraganglioma","route":"/cancers/metastatic-ppgl/"},{"id":"multiple-endocrine-neoplasia","kind":"cancer","name":"Multiple endocrine neoplasia syndromes (MEN1, MEN2, MEN4)","route":"/cancers/multiple-endocrine-neoplasia/"},{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"pancreatic-net","kind":"cancer","name":"Pancreatic neuroendocrine tumours","route":"/cancers/pancreatic-net/"},{"id":"pheochromocytoma-paraganglioma","kind":"cancer","name":"Pheochromocytoma and paraganglioma (PPGL)","route":"/cancers/pheochromocytoma-paraganglioma/"},{"id":"pituitary-tumours","kind":"cancer","name":"Pituitary tumours (pituitary neuroendocrine tumours) and pituitary carcinoma","route":"/cancers/pituitary-tumours/"},{"id":"small-intestinal-net","kind":"cancer","name":"Small intestinal neuroendocrine tumours","route":"/cancers/small-intestinal-net/"}],"technology":[{"id":"lu177-radioligand-therapy","kind":"technology","name":"Lutetium-177 radioligand therapy","route":"/technologies/lu177-radioligand-therapy/"},{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"},{"id":"radiopharmaceutical-gmp-release","kind":"technology","name":"Radiopharmaceutical GMP and releasing a drug that decays","route":"/technologies/radiopharmaceutical-gmp-release/"},{"id":"research-reactor-isotope-production","kind":"technology","name":"Research reactors for medical isotopes (Mo-99, Lu-177, I-131)","route":"/technologies/research-reactor-isotope-production/"},{"id":"sstr-pet","kind":"technology","name":"Somatostatin receptor PET (68Ga/64Cu-DOTATATE)","route":"/technologies/sstr-pet/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"term":[{"id":"prrt-term","kind":"term","name":"PRRT (peptide receptor radionuclide therapy)","route":"/terms/prrt-term/"},{"id":"sdh-deficiency","kind":"term","name":"SDH deficiency (SDHB immunohistochemistry loss)","route":"/terms/sdh-deficiency/"}],"trial":[{"id":"nct05142696","kind":"trial","name":"A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab","route":"/trials/nct05142696/"},{"id":"action-1","kind":"trial","name":"ACTION-1","route":"/trials/action-1/"},{"id":"netter-1","kind":"trial","name":"NETTER-1","route":"/trials/netter-1/"},{"id":"nct04711135","kind":"trial","name":"Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs","route":"/trials/nct04711135/"},{"id":"nct03972488","kind":"trial","name":"Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET","route":"/trials/nct03972488/"}],"pairing":[{"id":"prrt-then-alpha-net","kind":"pairing","name":"Beta PRRT → alpha 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therapy","route":"/drugs/i131-mibg/"}],"roadmap":[{"id":"radiopharma-roadmap","kind":"roadmap","name":"Radiopharmaceutical roadmap: iodine → lutetium → actinium","route":"/roadmaps/radiopharma-roadmap/"}],"person":[{"id":"emily-bergsland","kind":"person","name":"Emily K. Bergsland","route":"/people/emily-bergsland/"},{"id":"jonathan-strosberg","kind":"person","name":"Jonathan R. Strosberg","route":"/people/jonathan-strosberg/"},{"id":"ken-herrmann","kind":"person","name":"Ken Herrmann","route":"/people/ken-herrmann/"},{"id":"simron-singh","kind":"person","name":"Simron Singh","route":"/people/simron-singh/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}],"paper":[{"id":"paper-netter-2-lancet-2024","kind":"paper","name":"NETTER-2: lutetium-177 dotatate as first treatment for higher-grade gastroenteropancreatic neuroendocrine tumours","route":"/key-papers/paper-netter-2-lancet-2024/"}],"institution":[{"id":"chulabhorn-hospital","kind":"institution","name":"Chulabhorn Hospital / Chulabhorn Royal Academy","route":"/institutions/chulabhorn-hospital/"},{"id":"erasmus-mc","kind":"institution","name":"Erasmus MC Cancer Institute","route":"/institutions/erasmus-mc/"},{"id":"eanm","kind":"institution","name":"European Association of Nuclear Medicine","route":"/institutions/eanm/"},{"id":"iowa-holden","kind":"institution","name":"Holden Comprehensive Cancer Center, University of Iowa","route":"/institutions/iowa-holden/"},{"id":"inselspital-bern","kind":"institution","name":"Inselspital, Bern University Hospital / University Cancer Center Inselspital","route":"/institutions/inselspital-bern/"},{"id":"irst-meldola","kind":"institution","name":"IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST)","route":"/institutions/irst-meldola/"},{"id":"pgimer-chandigarh","kind":"institution","name":"Postgraduate Institute of Medical Education and Research, Chandigarh","route":"/institutions/pgimer-chandigarh/"},{"id":"snmmi","kind":"institution","name":"Society of Nuclear Medicine and Molecular Imaging","route":"/institutions/snmmi/"},{"id":"tum-munich","kind":"institution","name":"TUM Klinikum rechts der Isar / CCC München","route":"/institutions/tum-munich/"},{"id":"uppsala-akademiska","kind":"institution","name":"Uppsala University Hospital / Uppsala University","route":"/institutions/uppsala-akademiska/"},{"id":"essen-wtz","kind":"institution","name":"West German Cancer Center (WTZ), University Hospital Essen","route":"/institutions/essen-wtz/"}]}}