FDA Approves Bexlutry for Adults With Somatostatin Receptor Positive GEP Neuroendocrine Tumors
The U.S. Food and Drug Administration (FDA) has approved Bexlutry, also known as lutetium Lu 177 dotatate injection, for the treatment of adults with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP NETs). The approval was announced by Curium on September 14, 2026.
Bexlutry is indicated for adults with somatostatin receptor positive GEP NETs, including foregut, midgut, and hindgut neuroendocrine tumors. According to Curium, the product is the company's first radioligand therapy to receive FDA approval and is intended to expand access to lutetium based treatment in this area of oncology.
What are GEP neuroendocrine tumors?
Neuroendocrine tumors are cancers that develop from neuroendocrine cells. These specialized cells are found throughout the body and have characteristics of both nerve cells and hormone producing cells.
GEP NETs develop somewhere in the gastrointestinal tract or pancreas. They account for a substantial proportion of neuroendocrine tumors, with Curium estimating that they represent approximately 60% to 70% of all NETs.
The biological characteristics of these tumors can vary considerably. Some GEP NETs express somatostatin receptors on their surfaces. This receptor expression is important because it can provide a target for certain diagnostic and therapeutic approaches, including radioligand therapy.
How does Bexlutry work?
Bexlutry is a radioligand therapy. It combines a molecule that targets somatostatin receptors with the radioactive isotope lutetium Lu 177.
The treatment is designed to bind to somatostatin receptors on tumor cells and deliver radiation directly to those targeted cells. This approach is part of a broader field known as theranostics, which combines targeted diagnosis and treatment using related biological targets.
Bexlutry was approved through the FDA's 505(b)(2) regulatory pathway. Curium states that its application was supported by published evidence and bridging data intended to demonstrate a similar biological and chemical profile to an already approved radiopharmaceutical therapy, LUTATHERA, which also contains lutetium Lu 177 dotatate.
The FDA approval therefore represents a regulatory milestone for Curium while also adding another product to the treatment landscape for eligible adults with somatostatin receptor positive GEP NETs.
What did Curium say about the approval?
Renaud Dehareng, Curium's Group Chief Executive Officer, described the FDA approval as an important milestone in the company's expansion into oncology therapeutics. He also highlighted Curium's experience in nuclear medicine and its focus on supporting diagnosis and treatment through theranostic approaches.
Mike Patterson, Curium's North American Chief Executive Officer, said the company's vertically integrated manufacturing capabilities are intended to support the supply and delivery of Bexlutry to treatment centers.
The company says Bexlutry is now available for prescribing physicians and patient use.
Important safety considerations
As with other radiopharmaceutical treatments, Bexlutry has important safety considerations. The prescribing information warns that treatment contributes to a patient's cumulative radiation exposure. Radiation may also be detectable in urine for up to 30 days after administration. Appropriate radiation safety procedures are therefore required for patients, healthcare professionals, and household contacts.
The treatment can also cause myelosuppression, meaning a reduction in the production of blood cells. In the NETTER-1 clinical study, anemia, thrombocytopenia, and neutropenia occurred more frequently among patients receiving lutetium Lu 177 dotatate with long acting octreotide than among those receiving high dose long acting octreotide.
Long term risks also include secondary myelodysplastic syndrome and leukemia. The prescribing information reports cases of myelodysplastic syndrome and acute leukemia in clinical experience with lutetium Lu 177 dotatate.
Kidney toxicity is another important consideration. Amino acid solutions are administered before, during, and after treatment to reduce renal radiation exposure. Patients are also advised to maintain hydration and urinate frequently around treatment. Kidney function should be monitored during therapy.
Other warnings and precautions include hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis, embryo fetal toxicity, and potential infertility.
Because Bexlutry is a radioactive treatment, administration requires specialized facilities, appropriate monitoring, and radiation safety procedures.
Drug interactions and reproductive considerations
Somatostatin analogs can compete for somatostatin receptors and may interfere with the treatment. The prescribing information therefore provides specific instructions concerning the timing of long acting and short acting somatostatin analogs during Bexlutry treatment.
The prescribing information also advises avoiding repeated administration of high doses of glucocorticoids because these medicines can reduce expression of somatostatin receptor subtype 2.
Bexlutry may cause fetal harm. Women who could become pregnant should use effective contraception during treatment and for seven months after the final dose. Men with partners who could become pregnant are advised to use effective contraception during treatment and for four months following the last dose.
The treatment may also affect fertility in both men and women.
What the approval means
The approval of Bexlutry adds another FDA approved radioligand therapy option for adults with somatostatin receptor positive GEP NETs. Its use is specifically tied to the presence of somatostatin receptors and the treatment is administered in a setting equipped to handle radiopharmaceutical therapy.
For patients and healthcare professionals, the availability of another lutetium Lu 177 dotatate product may also have implications for treatment access and supply. Curium has emphasized its nuclear medicine infrastructure and manufacturing capabilities as part of its plans for the product's launch.
Patients considering Bexlutry should discuss whether the treatment is appropriate for their individual diagnosis, tumor characteristics, previous treatments, kidney and liver function, blood counts, reproductive plans, and other relevant medical factors.
Conclusion
FDA approval of Bexlutry marks Curium's entry into FDA approved radioligand therapy for oncology. The treatment is indicated for adults with somatostatin receptor positive GEP NETs, including foregut, midgut, and hindgut tumors.
The therapy uses lutetium Lu 177 to deliver targeted radiation to cells expressing somatostatin receptors. While this approach provides a targeted treatment strategy, Bexlutry also carries significant safety considerations related to radiation exposure, blood cell suppression, kidney function, liver toxicity, hypersensitivity, reproductive health, and other potential adverse effects.
The FDA approval provides an additional treatment option within the evolving field of radioligand therapy. Patients should rely on their oncology and nuclear medicine teams for individualized treatment decisions and advice.
Sources
- Curium, announcement of the FDA approval of Bexlutry, September 14, 2026.
- U.S. Food and Drug Administration, prescribing information for lutetium Lu 177 dotatate.
- Drugs.com, "Bexlutry (lutetium Lu 177 dotatate) FDA Approval History"
- Curium, Bexlutry prescribing and safety information.
Medical Disclaimer
This article is provided for general informational and educational purposes only. It is not medical advice, a diagnosis, or a recommendation for treatment. FDA approvals, prescribing information, indications, contraindications, and safety information can change. Patients should consult a qualified healthcare professional and review the current official prescribing information before making decisions about Bexlutry or any other cancer treatment.