Lutetium-177 dotatate
Lutetium-177 dotatate was the first modern radioligand therapy (2018), for neuroendocrine tumours, and is now used in first line.
Overview
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
PubChem holds the unlabelled ligand, so the radionuclide itself is not in this drawing.
SSTR2 agonist peptide with 177Lu. Connects to Somatostatin receptor 2.
- PSMA / SSTR-positive cell
1.Radioligand circulates and binds Somatostatin receptor 2 on tumour cells
- 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
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Novartis Patient Support (Patient Assistance NOW Oncology)
- PAN Foundation: Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- Unresectable or metastatic, progressive, well-differentiated somatostatin receptor-positive GEP-NETs
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA539 · SMC advice: lutetium-177 dotatate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Deals
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- 26 Sept 2017ApprovalEU
EMA approval: first modern PRRT source
- 26 Jan 2018ApprovalUS
SSTR+ gastroenteropancreatic NETs (NETTER-1) source
- 23 Apr 2024ApprovalUS
Paediatric patients ≥12 years source
- Jun 2024Label changeUS
First-line label based on NETTER-2 source
Approvals
| 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.
Trials
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Landmark trials
Patients newly diagnosed with an advanced grade 2 or 3 neuroendocrine tumour of the gut or pancreas that shows somatostatin receptors on imaging can now receive lutetium dotatate as their first treatment, gaining more than a year of additional disease control and a much higher chance of tumour shrinkage. It does not settle whether radioligand therapy is better than other first-line options such as capecitabine-temozolomide or everolimus, and long-term marrow safety with earlier use needs surveillance.
People treated with the radioactive drug lutetium-177 dotatate kept feeling well for much longer - years rather than months, in several measures - than people on the standard high-dose hormone injection, on top of the tumour-control benefit already shown.
In the largest reported group of neuroendocrine tumour patients treated with individually dosed radioactive peptide therapy, most people lived several years after treatment, and serious long-term harms such as blood cancers were uncommon but real, occurring in about 1 in 50 patients.
Latest papers
topQuery 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 (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR 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.
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