Lutetium Lu 177 Dotatate Approved for Adults With GEP-NETs

Curium announced on September 14, 2026, that the U.S. Food and Drug Administration (FDA) has approved BEXLUTRY (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. The approval was granted through the FDA’s 505(b)(2) pathway, with LUTATHERA (lutetium Lu 177 dotatate) as the reference product.

BEXLUTRY is described by Curium as the first radioligand equivalent for the treatment of GEP-NETs in adults and the company’s first radioligand therapy to receive FDA approval. The NDA was supported by published evidence and targeted bridging data demonstrating a similar biological and chemical profile to the previously approved reference therapy; specific comparative efficacy data from a head-to-head clinical trial were not disclosed.

Results and Safety

Because BEXLUTRY was approved via the 505(b)(2) pathway referencing LUTATHERA, its safety profile in the press announcement is drawn primarily from the NETTER-1 trial data associated with the reference product. In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with those receiving high-dose long-acting octreotide alone. Rates of anemia (all grades/grade 3 or 4) were 81%/0% versus 54%/1%; thrombocytopenia was reported in 53%/1% versus 17%/0%; and neutropenia in 26%/3% versus 11%/0%. Platelet nadir occurred at a median of 5.1 months following the first dose, and 68% of the 59 patients who developed thrombocytopenia experienced recovery to baseline or normal levels, with a median time to recovery of approximately 2 months.

Additional safety signals include the risk of secondary myelodysplastic syndrome (MDS) and leukemia. In NETTER-1, with a median follow-up of 76 months, MDS was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection. Radiation exposure is an inherent consideration with this class of therapy; radiation can be detected in the urine for up to 30 days following administration, and the prescribing information calls for minimizing exposure to patients, medical personnel, and household contacts consistent with institutional radiation safety practices and Nuclear Regulatory Commission guidance. The risks associated with radiation exposure are described as greater in pediatric patients than in adults. Efficacy data specific to BEXLUTRY, including response rates and progression-free survival, were not disclosed in the approval announcement.

Clinical Context

GEP-NETs account for an estimated 60–70% of all neuroendocrine tumors, which arise from neuroendocrine cells distributed broadly throughout the body’s organs. The approval of BEXLUTRY as a radioligand equivalent introduces a second commercially available lutetium Lu 177 dotatate product to the U.S. market, a development that may have implications for supply reliability and site-of-care access. Curium, which describes itself as the only vertically integrated lutetium-based NETs therapy manufacturer, has indicated that its end-to-end nuclear medicine infrastructure is intended to support consistent delivery and predictable scheduling for treatment centers.

The therapy’s practical impact will become clearer as it enters routine clinical use, including its effect on patient access, coverage, and real-world outcomes compared with the reference therapy. BEXLUTRY is described as immediately available for prescribing physicians and patient use.

Sources

• Curium Pharma. “Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs.” Press release. September 14, 2026. View source.