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Lutetium Lu 177 Dotatate
Lutetium Lu 177 Dotatate is a radioactive peptide that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation to kill them.
Lutetium Lu 177 Dotatate is a radioactive peptide that binds to somatostatin receptors on neuroendocrine tumor cells and delivers targeted radiation to kill them. Used for Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Somatostatin receptor-positive thoracic neuroendocrine tumors.
At a glance
| Generic name | Lutetium Lu 177 Dotatate |
|---|---|
| Also known as | 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium (177Lu) Oxodotreotide |
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Peptide receptor radionuclide therapy (PRRT) |
| Target | Somatostatin receptor 2 (SSTR2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
The drug consists of the peptide dotatate labeled with lutetium-177, a beta-emitting radioisotope. Dotatate binds with high affinity to somatostatin receptor subtype 2 (SSTR2) expressed on neuroendocrine tumor cells. Once bound, the lutetium-177 delivers localized radiation directly to tumor cells, causing DNA damage and cell death while minimizing exposure to healthy tissue.
Approved indications
- Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
- Somatostatin receptor-positive thoracic neuroendocrine tumors
Common side effects
- Nausea and vomiting
- Fatigue
- Abdominal pain
- Myelosuppression (anemia, thrombocytopenia, leukopenia)
- Renal toxicity
- Hepatotoxicity
Key clinical trials
- Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors (PHASE1)
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Targeted Therapy and Avelumab in Merkel Cell Carcinoma (PHASE1, PHASE2)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors (PHASE1)
- Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells (PHASE2)
- Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors (PHASE2)
- Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lutetium Lu 177 Dotatate CI brief — competitive landscape report
- Lutetium Lu 177 Dotatate updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI