BOSTON, Mass. — September 14, 2026
Curium™ announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for BEXLUTRY™ (lutetium Lu 177 dotatate injection) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors. The approval marks a major expansion of Curium’s nuclear medicine portfolio into oncology therapeutics and makes BEXLUTRY the company’s first FDA-approved radioligand therapy. Curium said BEXLUTRY is also the first radioligand equivalent approved for the treatment of GEP-NETs in adults. The product was approved through the FDA’s 505(b)(2) pathway, supported by published evidence and bridging data demonstrating comparable biological and chemical characteristics to the previously approved lutetium Lu 177 dotatate radiopharmaceutical. BEXLUTRY is now available for prescribing physicians and patient use in the United States..
BEXLUTRY Delivers Targeted Radiation to GEP-NETs
BEXLUTRY is designed to deliver targeted radiation directly to tumors expressing somatostatin receptors, providing a radioligand therapy approach for patients with GEP-NETs. The therapy uses lutetium-177 linked to dotatate, enabling the radioligand to bind to somatostatin receptors present on eligible neuroendocrine tumor cells and deliver therapeutic radiation. GEP-NETs account for approximately 60% to 70% of neuroendocrine tumors, which originate from specialized neuroendocrine cells distributed throughout the body. The FDA approval covers adults with SSTR-positive tumors originating in the foregut, midgut and hindgut. Curium’s development strategy builds on the established clinical and regulatory foundation for lutetium Lu 177 dotatate while introducing an additional manufacturing and supply option into the U.S. radioligand therapy market. For Curium, the approval represents an important step in applying its nuclear medicine expertise to targeted cancer treatment and theranostics.
Curium Strengthens Integrated Radioligand Manufacturing
The BEXLUTRY approval also advances Curium’s strategy to build an end-to-end oncology and nuclear medicine infrastructure. The company describes itself as a vertically integrated manufacturer of lutetium-based NET therapy and plans to support commercial delivery through its established nuclear medicine capabilities. Curium said its focus following approval will be a high-quality launch supported by reliable supply, predictable scheduling and site-of-care preparation for radioligand therapy. These capabilities are particularly important for radiopharmaceuticals because manufacturing, distribution, handling and administration require specialized infrastructure and coordinated logistics. Curium intends to leverage its experience in nuclear medicine to support healthcare facilities as they incorporate BEXLUTRY into their treatment operations. The launch therefore represents more than the introduction of a new product: it expands Curium’s role from traditional nuclear medicine services and diagnostics toward integrated diagnosis-to-therapy capabilities in oncology.
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BEXLUTRY Launch Expands Curium’s Oncology Strategy
BEXLUTRY provides Curium with a new commercial platform as the company expands its presence in radioligand therapy and precision oncology. The product is now available in the U.S., giving physicians access to an FDA-approved lutetium Lu 177 dotatate option for eligible adults with SSTR-positive GEP-NETs. At the same time, Curium will need to manage the specialized safety and operational requirements associated with radioligand therapy, including radiation exposure, blood-count monitoring, renal and hepatic monitoring, and appropriate radiation-safety procedures. The company’s broader strategy is built around combining its long-standing nuclear medicine infrastructure with targeted therapeutic technologies capable of extending precision medicine from diagnosis into treatment. The BEXLUTRY approval establishes Curium’s first FDA-approved radioligand therapy and provides a foundation for further expansion in oncology therapeutics. With U.S. commercial availability now underway, Curium is positioning BEXLUTRY as a key product in its transition toward a more comprehensive nuclear medicine and theranostics business.
Source: Curium press release
