FDA-approved
Digestive & weight
Lutetium Lu-177 dotatate
Lutetium Lu-177 dotatate (Lutathera) is an FDA-approved radiation therapy for neuroendocrine tumors. See how it works, uses, and side effects.
- Reviewed by
- William Maish, MD MBA MPH, Clinical Product Lead
- Published
- October 5, 2026
- Last updated
- October 5, 2026
Key takeaway
Lutetium Lu-177 dotatate (sold as Lutathera) is a targeted radiation therapy that attaches a radioactive isotope to a somatostatin analog to deliver radiation directly to neuroendocrine tumors. It was the first peptide receptor radionuclide therapy approved in the United States. It has been FDA-approved in the U.S. since 2018 and is given as a series of intravenous infusions.
At a glance
| What it is | A lutetium-177-labeled somatostatin analog delivering targeted radiation (peptide receptor radionuclide therapy) |
| Approved for | Somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors |
| Key fact | In the NETTER-1 trial it markedly improved progression-free survival versus high-dose octreotide |
| Route | Intravenous infusion, four doses eight weeks apart |
| Evidence strength | FDA approved |
What is lutetium Lu-177 dotatate?
Lutetium Lu-177 dotatate, sold under the brand Lutathera, uses the same tumor-seeking somatostatin analog as the imaging agent gallium-68 dotatate, but attaches a radiation-emitting isotope, lutetium-177, to treat rather than image. It is a form of peptide receptor radionuclide therapy (PRRT), and it was the first such therapy approved in the United States. It was approved in 2018.
How does lutetium Lu-177 dotatate work?
The dotatate peptide binds somatostatin receptor subtype 2 on neuroendocrine tumor cells and is taken inside them. Attached to it is lutetium-177, which emits beta particles, a short-range form of radiation. Because the tracer concentrates in receptor-rich tumor cells, the radiation is delivered largely where it is needed, damaging the DNA of the tumor cells and the cells immediately around them while sparing much of the healthy tissue.
This targeted delivery is the principle of PRRT, often described as a "theranostic" pairing with the gallium-68 imaging agent: the scan confirms the target before the therapy is given. In the NETTER-1 trial in advanced midgut neuroendocrine tumors, lutetium-177 dotatate markedly improved progression-free survival1 compared with high-dose octreotide. An amino-acid solution is infused alongside it to protect the kidneys.
Is it FDA-approved?
Yes. Lutetium Lu-177 dotatate (Lutathera) was approved2 by the FDA in 2018 for somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors in adults, with later expansion to adolescents. It is given as four intravenous infusions about eight weeks apart.
What is lutetium Lu-177 dotatate prescribed for?
It is prescribed for somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors, including those of the foregut, midgut, and hindgut. Eligibility is confirmed with somatostatin-receptor imaging such as the gallium-68 dotatate scan.
What are the side effects?
According to the prescribing information2, common side effects include:
- Nausea and vomiting, partly from the protective amino-acid infusion
- Fatigue
- Low blood counts
More serious considerations include:
- Bone-marrow suppression and a risk of secondary myelodysplastic syndrome or leukemia
- Kidney and liver toxicity
- A temporary surge of tumor hormones (neuroendocrine hormonal crisis)
- Allergic reactions, including swelling of the face or throat (angioedema)
- Radiation exposure and effects on fertility
More for digestive & weight
Sources: FDA prescribing information for Lutathera; the NETTER-1 trial (Strosberg et al., New England Journal of Medicine, 2017, DOI: 10.1056/NEJMoa16074271), indexed on PubMed. This document is educational and does not constitute medical advice.