FDA approves Bexlutry, first radioligand equivalent for gastroenteropancreatic neuroendocrine tumors

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.

GEP-NETs arise from neuroendocrine cells scattered throughout the digestive tract and pancreas and account for roughly 60% to 70% of all neuroendocrine tumors. These tumors commonly express somatostatin receptors, which Bexlutry targets to deliver radiation directly to tumor cells while limiting exposure to surrounding tissue.

Bexlutry is the first radioligand equivalent approved through FDA's 505(b)(2) pathway. The approval was supported by published evidence and bridging data demonstrating a similar biological and chemical profile to Lutathera, an already approved lutetium Lu 177 dotatate radiopharmaceutical.

Clinical experience with lutetium Lu 177 dotatate has shown that radioligand therapy can meaningfully delay disease progression in patients with somatostatin receptor-positive GEP-NETs and has become an established treatment option in advanced disease. The approval of Bexlutry provides an additional source of this therapeutic approach for clinicians managing patients who are candidates for peptide receptor radionuclide therapy.

Key safety considerations include radiation exposure, myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, and neuroendocrine hormonal crisis. To limit radiation exposure to the kidneys, patients receive an amino acid solution before, during, and after each infusion, along with hydration guidance. Common severe adverse reactions reported with lutetium Lu 177 dotatate included lymphopenia, nausea, vomiting, elevated liver enzymes, hyperglycemia, and hypokalemia. Clinicians should monitor blood counts as well as renal and hepatic function throughout treatment.

FDA's decision adds another radioligand therapy option to the neuroendocrine tumor treatment landscape and may help support treatment availability for eligible patients requiring somatostatin receptor-targeted radionuclide therapy.

Source: Curium. (2026 Sep 14). Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs