Lutathera

Lutathera is the brand name for lutetium-177 dotatate, a radiopharmaceutical used in targeted peptide receptor radionuclide therapy (PRRT) for certain neuroendocrine tumors. It combines a somatostatin analog with a lutetium-177 radioisotope via a DOTA chelator, enabling delivery of beta radiation to tumor cells while limiting exposure to most normal tissues. The radiopharmaceutical binds to somatostatin receptor subtype 2 (SSTR2) commonly expressed by gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Lutathera is indicated for adults with unresectable or metastatic, somatostatin receptor–positive GEP-NETs that have progressed on or after standard therapies. Tumors must be shown to express SSTR by Ga-68 DOTATATE PET imaging before treatment. It is not used for tumors lacking somatostatin receptor expression.

Administration involves intravenous infusions every 6 weeks for a total of four cycles. Each cycle administers 7.4 GBq (200 mCi) of lutetium-177, for a cumulative dose of 29.6 GBq (800 mCi). An amino acid solution is given during each cycle to protect renal function, and hydration and supportive care are commonly used. Dose adjustments may be made for kidney or bone marrow function.

In clinical trials, Lutathera plus standard care improved progression-free survival and response rates versus control therapy, supporting its approval in this indication. Common adverse effects include nausea, vomiting, diarrhea, fatigue, and hematologic toxicity (anemia, thrombocytopenia, leukopenia). Potential renal toxicity and, rarely, therapy-related myelodysplastic syndromes or leukemia require monitoring of blood counts and kidney function.

Regulatory status: Lutathera was approved by the FDA for somatostatin receptor–positive GEP-NETs in 2018 and has been authorized in other regions since 2017.