The FDA has approved lutetium Lu 177 dotatate injection (Bexlutry) for patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults, according to a press release from Curium.
The approval is based on results from the ERASMUS trial. The press release highlighted warnings and precautions including risk of toxicity from radiation exposure, myelosuppression, secondary myelodysplastic syndrome and leukemia, and renal toxicity.
A recommended amino acid solution must be administered before, during, and after treatment so patients can reabsorb lutetium Lu 177 dotatate through proximal tubules, which in turn decreases the radiation dose to the kidneys. Clinicians are advised to tell patients to hydrate frequently before, during, and after treatment.
Additional monitoring should be done for serum creatinine and calculated creatinine clearance. Clinicians are advised to withhold the dose, reduce the dose, or discontinue treatment in the event of severe renal toxicity.
Patients may experience hepatotoxicity or hypersensitivity reactions. Additional warnings include neuroendocrine hormonal crisis, embryo-fetal toxicity, and risk of infertility.
Drug interactions may occur with somatostatin analogs or glucocorticoids. Patients should not breastfeed for 2.5 months post-treatment.
“FDA approval of [lutetium Lu 177 dotatate injection] is a defining milestone for Curium as we expand our offering into oncology therapeutics. With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence,” Renaud Dehareng, Curium’s chief executive officer, said in the press release.
Reference
Curium™ announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs. News release. September 14, 2026. Accessed September 14, 2026. https://tinyurl.com/4rjhkzym
