OnCo
drugsProductPhase 3

177Lu-edotreotide

A second lutetium radioligand for neuroendocrine tumours that beat the standard pill everolimus in a head-to-head trial and is awaiting an FDA decision.

COMPETE (Lancet 2025; 309 patients, grade 1-2 GEP-NETs): PFS 23.9 vs 14.1 months versus everolimus (HR 0.67); ORR significantly higher; interim OS 63.4 vs 58.7 months not significant (HR 0.78). Uses non-carrier-added 177Lu from ITM's own supply. NDA accepted with PDUFA 28 August 2026. COMPOSE (grade 2-3, versus CAPTEM/everolimus/FOLFOX) ongoing.

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DOTATOC (edotreotide) · 2D coordinates (no PubChem conformer)
PubChem
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Radioligand therapy (beta emitters)
Modality
Radioligand therapy (beta)
Mechanism
DOTATOC peptide (SSTR2 agonist) chelating 177Lu; four cycles of 7.5 GBq every 3 months.
Brand / code
ITM-11, n.c.a. 177Lu-DOTATOC
Dosing & schedule
Route
Intravenous
Schedule
7.5 GBq every 3 months × 4 with amino-acid renal protection

Regulatory

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  1. Mar 2025DesignationUS

    COMPETE topline at ENETS 2025 source

  2. 28 Aug 2026PDUFA dateUS

    PDUFA goal date for GEP-NET indication source

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
177Lu-edotreotide
intervention: 177Lu-edotreotide
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Landmark trials in OnCo

Latest papers

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Literature trend0 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"177Lu-edotreotide" OR ABSTRACT:"177Lu-edotreotide" OR TITLE:"ITM-11" OR ABSTRACT:"ITM-11" OR TITLE:"n.c.a. 177Lu-DOTATOC" OR ABSTRACT:"n.c.a. 177Lu-DOTATOC") 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 177Lu-edotreotide, not a curated reading list.

Connected

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