The US 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). Bexlutry is a generic version of Novartis’ Lutathera and was developed by Curium.
NETs are rare tumors that usually develop in the gastrointestinal tract or lungs, but may develop in other parts of the body, such as the pancreas, testicle, or ovary. The tumor may produce hormone-like substances that spread to the body and cause symptoms of carcinoid syndrome, such as flushing of the face and chest, diarrhea, and trouble breathing. Symptoms may vary depending on where the tumor is located. NETs can be difficult diagnose due to their clinically challenging presentation. The cause of NETs is unknown.
Bexlutry is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors often expressed on these tumors.
Bexlutry is approved through the FDA’s 505(b)(2) New Drug Application pathway, supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to Lutathera, the previously approved radiopharmaceutical therapy.
The approval for the original Luthathera therapy, was based on the pivotal phase 3 NETTER-1 clinical trial (NCT01578239) in which 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors received either lu 177 dotatate or octreotide LAR alone. Results were published in The New England Journal of Medicine.
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To learn more about NETs and other rare endocrine disorders, visit https://checkrare.com/diseases/endocrine-disorders/