The FDA has approved Curium’s Bexlutry, or lutetium Lu 177 dotatate injection, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
The approval covers foregut, midgut and hindgut neuroendocrine tumors. Bexlutry is a radioligand therapy designed to bind to somatostatin receptors expressed on gastroenteropancreatic neuroendocrine tumors and deliver radiation to those tumors.
Curium said Bexlutry was approved through the FDA’s 505(b)(2) pathway. The application was supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy, LUTATHERA.
Gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, originate from neuroendocrine cells found throughout the body’s organs. Curium said GEP-NETs account for 60% to 70% of neuroendocrine tumors.
Bexlutry is available for prescribing physicians and patient use, the company said.
The prescribing information includes warnings related to radiation exposure, myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis, embryo-fetal toxicity and infertility.
Radiation from Bexlutry can be detected in urine for up to 30 days after administration. The drug contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer.
In the NETTER-1 study, anemia occurred in 81% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide, thrombocytopenia in 53% and neutropenia in 26%.
The most common Grade 3 or 4 adverse reactions reported in NETTER-1 included lymphopenia, increased gamma-glutamyl transferase, vomiting, nausea, increased liver enzymes, hyperglycemia and hypokalemia.
Curium said Bexlutry is its first FDA-approved radioligand therapy.
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