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Lutetium-177 dotatate was the first modern radioligand therapy (2018), for neuroendocrine tumours, and is now used in first line.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
SSTR2 agonist peptide with 177Lu. Connects to Somatostatin receptor 2.
1.Radioligand circulates and binds Somatostatin receptor 2 on tumour cells
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS A9513. Four doses eight weeks apart.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Somatostatin receptor-positive GEP-NET on an approved PET scan.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA539 · SMC advice: lutetium-177 dotatate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
EMA approval: first modern PRRT source
SSTR+ gastroenteropancreatic NETs (NETTER-1) source
Paediatric patients ≥12 years source
First-line label based on NETTER-2 source
| Region | Year | Indication |
|---|---|---|
| US | 2018 | SSTR+ GEP-NETs |
| US | 2024 | Paediatric ≥12 years; first-line (NETTER-2 label) |
| EU | 2017 | First approval globally (Sep 2017) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Lymphopenia NETTER-1; grade 3-4 rates | - | 44% |
| GGT increased NETTER-1; grade 3-4 rates | - | 20% |
| Vomiting NETTER-1; grade 3-4 rates | - | 7% |
| Nausea NETTER-1; grade 3-4 rates | - | 5% |
| AST increased NETTER-1; grade 3-4 rates | - | 5% |
| ALT increased NETTER-1; grade 3-4 rates | - | 4% |
| Hyperglycaemia NETTER-1; grade 3-4 rates | - | 4% |
| Hypokalaemia NETTER-1; grade 3-4 rates | - | 4% |
| Myelodysplastic syndrome Median onset 29 months | 2.3% | - |
| Acute leukaemia NETTER-1; grade 3-4 rates | 0.5% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | ~$47,500 per dose (launch price 2018) | - |
| United Kingdom | NICE: recommended for unresectable/metastatic GEP-NETs (TA539) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Lutetium-177 dotatate" OR ABSTRACT:"Lutetium-177 dotatate" OR TITLE:"Lutathera" OR ABSTRACT:"Lutathera" OR TITLE:"177Lu-DOTATATE" OR ABSTRACT:"177Lu-DOTATATE") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lutetium-177 dotatate, not a curated reading list.
Shares SSTR PET → PRRT, Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, Somatostatin receptor expression by PET (SSTR-positive), Chulabhorn Hospital / Chulabhorn Royal Academy.
Shares Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier, Beta radioligand → alpha radioligand, Chulabhorn Hospital / Chulabhorn Royal Academy.
Shares Somatostatin receptor expression by PET (SSTR-positive), PRRT (peptide receptor radionuclide therapy), Radiopharmaceutical GMP and releasing a drug that decays, Somatostatin receptor PET (68Ga/64Cu-DOTATATE).
Shares Dosimetry-personalised PRRT instead of four fixed cycles, PRRT (peptide receptor radionuclide therapy), IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST), European Association of Nuclear Medicine.
Shares ACTION-1, Beta radioligand → alpha radioligand, Somatostatin receptor expression by PET (SSTR-positive), Radiopharmaceutical roadmap: iodine → lutetium → actinium.
Shares NETTER-1, PRRT (peptide receptor radionuclide therapy), Cancer of unknown primary, favourable subsets, Grade 3 well-differentiated neuroendocrine tumour.
Shares SSTR PET → PRRT, Dosimetry-personalised PRRT instead of four fixed cycles, Grade 3 well-differentiated neuroendocrine tumour, Peptide receptor radionuclide therapy (PRRT).
Shares Jonathan R. Strosberg, Dosimetry-personalised PRRT instead of four fixed cycles, Grade 3 well-differentiated neuroendocrine tumour, Peptide receptor radionuclide therapy (PRRT).