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.
- Route
- Intravenous
- Schedule
- 7.5 GBq every 3 months × 4 with amino-acid renal protection
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Trials
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Landmark trials in OnCo
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topQuery 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.