BEXLUTRY Becomes First FDA-Approved Radioligand Equivalent for Adults With SSTR-Positive Gastroenteropancreatic Neuroendocrine Tumors

Clinical Summary: 

• Regulatory Action: The FDA approved BEXLUTRY (lutetium Lu 177 dotatate; Curium) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut tumors.
• Supporting Evidence: BEXLUTRY was approved through the FDA’s 505(b)(2) pathway as a radioligand equivalent to LUTATHERA, based on published evidence and targeted bridging data demonstrating a similar biological and chemical profile to the previously approved lutetium Lu 177 dotatate product.
• Clinical Relevance: The approval introduces an additional targeted radioligand therapy option for adults with SSTR-positive GEP-NETs and represents the first FDA-approved radioligand equivalent in this disease setting.

The US Food and Drug Administration (FDA) has approved BEXLUTRY (lutetium Lu 177 dotatate; Curium) for the treatment of adults with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut tumors.

BEXLUTRY is a radioligand therapy designed to deliver targeted radiation to tumor cells expressing somatostatin receptors. The agent binds to SSTR-expressing neuroendocrine tumor cells, allowing lutetium-177 to deliver localized radiation to the tumor. 

The therapy was approved through the FDA’s 505(b)(2) regulatory pathway as a radioligand equivalent to lutetium Lu 177 dotatate (LUTATHERA). The application was supported by previously published evidence as well as targeted bridging data demonstrating a similar biological and chemical profile to the previously approved radiopharmaceutical therapy.

BEXLUTRY represents the first FDA-approved radioligand equivalent for GEP-NETs and the first radioligand therapy from Curium to receive FDA approval.

The prescribing information includes warnings and precautions related to radiation exposure, myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis, embryo-fetal toxicity, and infertility.

Myelosuppression associated with lutetium Lu 177 dotatate has included anemia, thrombocytopenia, and neutropenia. Blood cell counts should be monitored during therapy, with treatment interruption, dose reduction, or permanent discontinuation based on severity.

Long-term treatment-related risks include secondary myelodysplastic syndrome and acute leukemia. Renal toxicity is another recognized risk of lutetium Lu 177 dotatate therapy; administration of an amino acid solution before, during, and after treatment is recommended to reduce renal radiation exposure. Patients should also be appropriately hydrated and monitored for changes in renal function.

The most common grade 3/4 adverse reactions reported with lutetium Lu 177 dotatate in NETTER-1 included lymphopenia, increased gamma-glutamyl transferase, vomiting, nausea, increased aspartate aminotransferase, increased alanine aminotransferase, hyperglycemia, and hypokalemia.

Because somatostatin analogs may interfere with receptor binding, long-acting somatostatin analogs should be discontinued at least 4 weeks before each BEXLUTRY dose, while short-acting octreotide should be discontinued at least 24 hours before treatment. Repeated administration of high-dose glucocorticoids should also be avoided because of their potential to downregulate SSTR2 expression.

The approval provides another radioligand therapy option for adults with SSTR-positive GEP-NETs and may broaden availability of lutetium Lu 177 dotatate treatment across eligible patients and treatment centers.

Source:

Curium. Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs. Accessed on September 15, 2026. https://www.curiumpharma.com/2026/09/14/fda-approval-bexlutry/