The U.S. Food and Drug Administration (FDA) has approved Bexlutry (lutetium Lu 177 dotatate) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (SSTR-positive GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors.
Curium announced the approval on September 14, 2026. According to the company, Bexlutry is the first radioligand equivalent for the treatment of GEP-NETs in adults and represents Curium’s first FDA-approved radioligand therapy. The treatment is now available for prescribing physicians and eligible patients in the United States.
What Is Bexlutry?
Bexlutry is a lutetium Lu 177 dotatate radioligand therapy designed to selectively deliver radiation to tumor cells expressing somatostatin receptors.
Many neuroendocrine tumors express high levels of somatostatin receptors. Lutetium Lu 177 dotatate binds to these receptors, allowing the radioactive isotope lutetium-177 to deliver radiation directly to receptor-positive tumor cells.
Gastroenteropancreatic neuroendocrine tumors develop from neuroendocrine cells within the gastrointestinal tract and pancreas. Curium estimates that GEP-NETs account for approximately 60% to 70% of neuroendocrine tumors.
FDA Approval Through the 505(b)(2) Pathway
Bexlutry was approved through the FDA’s 505(b)(2) New Drug Application pathway, with Lutathera (lutetium Lu 177 dotatate) serving as the reference product.
According to Curium, the application was supported by previously published clinical evidence together with targeted bridging data demonstrating a similar biological and chemical profile to the previously approved radiopharmaceutical therapy.
Lutetium Lu 177 dotatate was originally approved by the FDA in 2018 for adults with SSTR-positive GEP-NETs. In 2024, the indication for Lutathera was expanded to include pediatric patients aged 12 years and older. Bexlutry’s current FDA indication is specifically for adult patients.
Renaud Dehareng, Group Chief Executive Officer of Curium, described the approval as a major step in the company’s expansion into oncology therapeutics, saying:
“FDA approval of BEXLUTRY is a defining milestone for Curium as we expand our offering into oncology therapeutics.”
He added that the company intends to use its nuclear medicine infrastructure to expand access to radioligand therapy for eligible patients.
Evidence Supporting Lutetium Lu 177 Dotatate
Clinical evidence for lutetium Lu 177 dotatate includes the pivotal Phase 3 NETTER-1 trial (NCT01578239), which enrolled 229 patients with advanced, SSTR-positive midgut neuroendocrine tumors that had progressed during treatment with octreotide. Results were published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa1607427)
Patients were randomized to receive lutetium Lu 177 dotatate plus long-acting octreotide or high-dose long-acting octreotide alone.
In the study, the estimated progression-free survival rate at 20 months was 65.2% with lutetium Lu 177 dotatate compared with 10.8% in the control group. The objective response rate was 18% versus 3%, respectively.
FDA’s review of the original lutetium Lu 177 dotatate application reported a hazard ratio for disease progression or death of 0.21, corresponding to a substantial reduction in the risk of progression or death compared with high-dose octreotide.
Safety of Bexlutry
Warnings and precautions associated with Bexlutry include risks related to radiation exposure, myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis, embryo-fetal toxicity and infertility.
In NETTER-1, hematologic toxicities occurred more frequently with lutetium Lu 177 dotatate than with high-dose octreotide. The Bexlutry prescribing information recommends monitoring blood counts and renal and hepatic function during treatment and using an amino acid solution to reduce radiation exposure to the kidneys.
The recommended cumulative dose is 29.6 GBq, consistent with four administrations of lutetium Lu 177 dotatate therapy.
Expanding Access to Radioligand Therapy
The approval introduces another lutetium Lu 177 dotatate product into the U.S. market for adults with SSTR-positive GEP-NETs.
Curium said its vertically integrated lutetium manufacturing and nuclear medicine infrastructure are intended to support reliable supply, treatment scheduling, and broader delivery of radioligand therapy across treatment centers.
The approval also marks Curium’s expansion from its established nuclear medicine and diagnostic portfolio into FDA-approved therapeutic radiopharmaceuticals.
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