Edotreotide yttrium Y-90

Summary

Yttrium-90 DOTA-TOC (Y-90 edotreotide) is a radiolabeled somatostatin analogue used in peptide receptor radionuclide therapy (PRRT) for somatostatin receptor-positive neuroendocrine tumors (NETs). It delivers targeted beta-radiation to tumor cells expressing SSTR2. Approved in Europe under the brand name OctreoTher; used clinically in multiple centers worldwide. Lutetium-177 DOTATATE (Lutathera) has largely become the preferred PRRT agent in the US, but Y-90 edotreotide remains in clinical use in Europe.

Mechanism of Action

Edotreotide (DOTA-TOC) is a somatostatin analogue that binds with high affinity to somatostatin receptor subtype 2 (SSTR2) overexpressed on neuroendocrine tumor cells. When chelated with yttrium-90 (Y-90), it delivers targeted beta-radiation to receptor-expressing tumor cells, inducing DNA damage and cell death via peptide receptor radionuclide therapy (PRRT).

Routes of Administration

Goals & Uses

• Symptom control in functional NETsSymptom ManagementModerate
• Tumor downsizing prior to surgeryOncologyModerate
• Treatment of somatostatin receptor-positive neuroendocrine tumorsOncologyHigh
• Metastatic paraganglioma / pheochromocytomaOncologyLow

Contraindications

• Hepatic decompensation / liver metastases >70% liver replacementHepaticModerate
• Severe renal impairmentOrganHighKidney function concerns
• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• BreastfeedingPopulationHighPotential transfer into breast milk or insufficient safety data
• Hypersensitivity to DOTA-TOC or somatostatin analoguesImmunologicHigh
• Severe bone marrow suppressionHematologicHigh

Adverse Effects

• Myelosuppression (thrombocytopenia, leukopenia)HematologicCommon
• Nausea and vomitingGastrointestinalCommon
• FatigueGeneralCommonLow energy or tiredness
• Radiation-induced hepatotoxicityHepaticUncommon
• Secondary myelodysplastic syndrome / leukemiaHematologicRare
• NephrotoxicityRenalCommon

Drug Interactions

• Nephrotoxic agents (aminoglycosides, NSAIDs, contrast agents)High
• Myelosuppressive chemotherapyModerate
• Long-acting somatostatin analogues (octreotide LAR, lanreotide)Moderate

Population Constraints

• Patients with prior external beam radiation to kidneys or bone marrowPrior TherapyRelative
• Pediatric patientsAgeRelative
• Elderly patients (>70 years)AgeRelative
• Patients with renal impairment (GFR <40 mL/min)RenalRelative

Regulatory Status

• European UnionApprovedApproved: Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumorsOctreoTher approved in Switzerland; used under national authorization/named-patient programs in various EU countries. Regulatory status varies by member state.
• United StatesUnapprovedNot FDA-approved. Lu-177 DOTATATE (Lutathera) is the approved PRRT in the US for SSTR-positive GEP-NETs. Y-90 DOTA-TOC may be available through clinical trials or compassionate use.
• United KingdomUnknownPost-Brexit regulatory status uncertain; likely available through specialist centers on named-patient or compassionate use basis.

Approved in Switzerland and used under various national regulatory frameworks in Europe. Not FDA-approved in the United States; Lutathera (Lu-177 DOTATATE) is the FDA-approved PRRT. EMA approval status has been complex; OctreoTher was approved in Switzerland and used under compassionate/named-patient programs across Europe.

Evidence & Sources

No sources recorded yet.