OnCo
drugsProductApproved2018🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

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.

Loading structure…
|
DOTATATE (oxodotreotide) · 2D coordinates (no PubChem conformer)
PubChem
How it works, step by step · animated schematic, not to scale
Radioligand therapy (beta emitters)
Mechanism, step by step
auto-advancing · hover to pause

1.Radioligand circulates and binds Somatostatin receptor 2 on tumour cells

Modality
Radioligand therapy (beta)
Mechanism
SSTR2 agonist peptide with 177Lu.
Brand / code
Lutathera · 177Lu-DOTATATE
Dosing & schedule
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.

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.

NICE recommendedNICE TA539 · 2018SMC: accepted
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.

Regulatory

4top
  1. 26 Sept 2017ApprovalEU

    EMA approval: first modern PRRT source

  2. 26 Jan 2018ApprovalUS

    SSTR+ gastroenteropancreatic NETs (NETTER-1) source

  3. 23 Apr 2024ApprovalUS

    Paediatric patients ≥12 years source

  4. Jun 2024Label changeUS

    First-line label based on NETTER-2 source

Approvals

RegionYearIndication
US2018SSTR+ GEP-NETs
US2024Paediatric ≥12 years; first-line (NETTER-2 label)

Safety

10top
Toxicity profile
Adverse eventAny gradeGrade 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.

Cost & access

2top
Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: recommended for unresectable/metastatic GEP-NETs (TA539)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
66 studies25 recruiting54 Phase 214 Phase 3
Search “Lutetium-177 dotatate” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Lutetium-177 dotatate
intervention: Lutetium-177 dotatate
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Key papers

1top

Latest papers

top
Literature trend61 papers in the last 12 months+5% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

28top

Pages like this

not linked directly; found by shared links