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Lutathera (lutetium (177Lu) oxodotreotide)
Lutathera works by binding to somatostatin receptors on neuroendocrine tumor cells, delivering a radioactive dose that kills the cells.
Lutathera (lutetium (177Lu) oxodotreotide) is a small molecule radiopharmaceutical that targets somatostatin receptor type 2. It is used to treat neuroendocrine tumors and was originally developed by AAA USA INC, with the current owner also being AAA USA INC. Lutathera was FDA approved in 2018 and is a patented product. Key safety considerations include radiation exposure and potential effects on bone marrow and kidneys. It is essential to monitor patients for these potential side effects.
At a glance
| Generic name | lutetium (177Lu) oxodotreotide |
|---|---|
| Sponsor | Aaa Usa Inc |
| Target | Somatostatin receptor type 2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 190 |
Mechanism of action
Imagine a key that fits into a lock on the surface of cancer cells. Lutathera is like that key, which binds to a specific receptor on the surface of neuroendocrine tumor cells. Once bound, it delivers a small amount of radiation that kills the cell.
Approved indications
- Neuroendocrine tumor
Common side effects
- Ill-defined disorder
- Laboratory test abnormal
- COVID-19
- Illness
- Platelet count decreased
- Metastases to liver
- Disease progression
- SARS-CoV-2 test positive
- Blood chromogranin A increased
- Neuroendocrine tumour
- Thrombocytopenia
- Hepatic lesion
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lutathera CI brief — competitive landscape report
- Lutathera updates RSS · CI watch RSS
- Aaa Usa Inc portfolio CI