Lutetium-177 dotatate
Lutetium-177 dotatate was the first modern radioligand therapy (2018), for neuroendocrine tumours, and is now used in first line.
NETTER-1 (midgut NETs after octreotide) and NETTER-2 (2024; first-line high-grade-2/3 GEP-NETs, PFS 22.8 vs 8.5 months). Paediatric approval 2024. Alpha-emitting successors RYZ101 and AlphaMedix are in phase 3.
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.
- 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) |
| 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
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
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Pages like this
not linked directly; found by shared links- TermTheranostics
Shares Regional radiopharmacy hubs and harmonised transport rules for short-lived isotopes, SSTR PET → PRRT, Somatostatin receptor PET (68Ga/64Cu-DOTATATE), Chulabhorn Hospital / Chulabhorn Royal Academy.
- ProductLutetium-177 vipivotide tetraxetan
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.
- TermDosimetry
Shares Dosimetry-personalised PRRT instead of four fixed cycles, NETTER-2: lutetium-177 dotatate as first treatment for higher-grade gastroenteropancreatic neuroendocrine tumours, IRCCS Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' (IRST), European Association of Nuclear Medicine.
- Product177Lu-edotreotide
Shares SSTR PET → PRRT, Dosimetry-personalised PRRT instead of four fixed cycles, Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2.
- ProductActinium-225 DOTATATE
Shares ACTION-1, Beta radioligand → alpha radioligand, Peptide receptor radionuclide therapy (PRRT), Radiopharmaceutical roadmap: iodine → lutetium → actinium.
- CompanyITM Isotope Technologies Munich
Shares Build Western ytterbium-176 enrichment so lutetium-177 has more than one supplier, Peptide receptor radionuclide therapy (PRRT), Radiopharmaceutical roadmap: iodine → lutetium → actinium, Somatostatin receptor 2.
- TechnologyTargeted alpha therapy
Shares ACTION-1, Beta PRRT → alpha PRRT, Beta radioligand → alpha radioligand, Chulabhorn Hospital / Chulabhorn Royal Academy.
- ProductGallium-68 DOTATATE (and Cu-64 DOTATATE)
Shares Somatostatin receptor PET (68Ga/64Cu-DOTATATE), Peptide receptor radionuclide therapy (PRRT), Somatostatin receptor 2, Novartis.