BOSTON, September 18 — Curium, the nuclear medicine company headquartered here, announced on September 14 that the U.S. Food and Drug Administration has approved its New Drug Application for BEXLUTRY lutetium Lu 177 dotatate injection, a radioligand therapy for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. The approval covers foregut, midgut and hindgut neuroendocrine tumors. BEXLUTRY is designed to deliver targeted radiation to these tumors by binding to somatostatin receptors commonly expressed on them.
For patients and the specialists who treat them, the decision adds a second lutetium-based option in a field where supply and access have long shaped care. GEP-NETs account for 60-70% of all neuroendocrine tumors, according to the announcement.
NETs originate from neuroendocrine cells, specialized cells widely dispersed throughout the body’s organs, which is why the site of origin can vary so much from one patient to the next.
What the FDA cleared, and how
The agency granted the approval through the 505(b)(2) pathway, which allows an applicant to rely on existing data for a previously approved drug. BEXLUTRY targets LUTATHERA, also lutetium Lu 177 dotatate, and was supported by published evidence and targeted bridging data showing a similar biological and chemical profile to a previously approved radiopharmaceutical therapy. Curium described BEXLUTRY as the first radioligand equivalent for the treatment of GEP-NETs in adults, and the first radioligand therapy from Curium to win FDA approval.
Renaud Dehareng, Curium’s Group Chief Executive Officer, called the approval a defining milestone for the company as it expands into oncology therapeutics. In the announcement, he pointed to Curium’s long-standing commitment to the NET community and said the company is now bringing the full diagnosis-to-therapy capability needed to scale theranostics responsibly.
He added that Curium has earned trust in nuclear medicine through reliability, quality and day-in, day-out delivery, and that it is applying that same discipline to help eligible NET patients access radioligand therapy with confidence. Mike Patterson, Curium’s North American Chief Executive Officer, said in the same announcement that Curium is the only vertically integrated, lutetium-based NETs therapy manufacturer, a position he said allows it to support a reliable supply of BEXLUTRY and help sites of care prepare for radioligand therapy delivery at scale.
The remainder of his statement was truncated in the source material.
Supply, scale and what comes next
No financial terms, pricing or launch dates were disclosed. The announcement was distributed via GlobeNewswire on September 14, 2026, at 17:49 ET. Curium is based in Boston, Massachusetts.
What to watch next is whether the approval translates into broader access at treatment sites that must be equipped to handle radiopharmaceutical delivery, and how quickly the company moves from regulatory clearance to commercial supply. Consult your doctor for medical advice.
