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BEXLUTRY is the first radioligand equivalent for the treatment of GEP-NETs in adults and the first radioligand therapy from Curium™ approved by the FDA
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BOSTON, Sept. 14, 2026 (GLOBE NEWSWIRE) — Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY™ lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
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BEXLUTRY™ is a radioligand therapy designed to deliver targeted radiation to GEP-NETs by binding to somatostatin receptors commonly expressed on these tumors. NETs originate from neuroendocrine cells, which are specialized cells widely dispersed throughout the body’s organs. The site of origin can vary because of the broad distribution of neuroendocrine cells. GEP-NETs represent 60-70% of NETs.
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BEXLUTRY™ is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA® (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy.
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Renaud Dehareng, Curium’s Group Chief Executive Offer, said: “FDA approval of BEXLUTRY™ is a defining milestone for Curium™ as we expand our offering into oncology therapeutics. With over 100 years of experience in nuclear medicine and a long-standing commitment to the NET community, we are now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly. For decades, Curium™ has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery. We are applying that same discipline and commitment to help eligible NET patients access radioligand therapy with confidence.”
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Mike Patterson, Curium’s North American Chief Executive Officer, said: “As the only vertically integrated, lutetium-based NETs therapy manufacturer, Curium™ is uniquely positioned to support a reliable supply of BEXLUTRY™ and help sites of care prepare for radioligand therapy delivery at scale. Today’s FDA approval brings us a step closer to advancing our ambition of aiming to improve the lives of up to 80% of patients with cancer. Our priority now is a high-quality launch supported by our end-to-end nuclear medicine infrastructure, designed to help ensure consistent delivery, predictable scheduling support for sites of care, and a dependable experience for patients receiving radioligand therapy.”
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BEXLUTRY™ is now available for prescribing physicians and patient use. Visit www.bexlutry.com.
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About BEXLUTRY™
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INDICATIONS AND USAGE
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Bexlutry™ (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.