Curium has received U.S. Food and Drug Administration (FDA) approval for its lutetium 177 (Lu-177) dotatate injection (Bexlutry) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
These include foregut, midgut, and hindgut neuroendocrine tumors in adults.
Bexlutry is a radioligand therapy that delivers targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors. It was approved through the FDA's 505(b)(2) pathway as a radioligand equivalent to the Lutathera Lu-177 dotatate, supported by published evidence and bridging data demonstrating a similar biological and chemical profile. GEP-NETs represent 60% to 70% of all neuroendocrine tumors.
Curium said Bexlutry is now available for prescribing.
