Curium wins FDA approval for BEXLUTRY lutetium RLT in GEP-NETs

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.

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Curium has secured FDA approval for BEXLUTRY (lutetium Lu 177 dotatate injection), a radioligand therapy (RLT) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, including foregut, midgut, and hindgut GEP-NETs. The approval, announced on 14 September 2026, marks Curium's formal entry into the oncology therapeutics market after a century-long heritage in nuclear medicine diagnostics.

BEXLUTRY was approved via the FDA's 505(b)(2) regulatory pathway, referencing Novartis-owned LUTATHERA (lutetium Lu 177 dotatate) as the reference listed drug. Curium submitted bridging data demonstrating a comparable biological and chemical profile, alongside published evidence from the NETTER-1 and ERASMUS clinical studies that underpin the originator's label. The safety profile carried into the BEXLUTRY prescribing information reflects those trials: key Grade 3-4 adverse reactions in NETTER-1 included lymphopenia, elevated liver enzymes, nausea, vomiting, hyperglycaemia, and hypokalaemia. Longer-term data from ERASMUS, with a median follow-up exceeding four years, recorded myelodysplastic syndrome in 2% of patients and renal failure in a further 2%, underscoring the monitoring requirements that will accompany clinical adoption.

The competitive landscape

LUTATHERA, approved by the FDA in 2018, has been the sole lutetium-177 dotatate product available in the United States for GEP-NETs. Curium's entry introduces the first competitor in this specific radioligand class, and the company is positioning supply reliability as its primary differentiator. Mike Patterson, Curium's North American chief executive, described the company as "the only vertically integrated, lutetium-based NETs therapy manufacturer," a claim centred on Curium's four manufacturing sites and distribution network spanning more than 70 countries.

Vertical integration matters in radiopharmaceuticals more than in most drug classes. Lutetium-177 has a half-life of roughly 6.7 days, which places extreme demands on logistics and scheduling. Supply disruptions at the isotope production or manufacturing stage translate directly into missed patient doses. Curium's existing infrastructure, built over decades supplying diagnostic radiopharmaceuticals, may offer a genuine operational advantage over sponsors entering theranostics without that base.

Market context and regulatory read-across

The broader theranostics sector is attracting significant commercial interest. Novartis's PLUVICTO (lutetium Lu 177 vipivotide tetraxetan), approved in 2022 for metastatic castration-resistant prostate cancer, demonstrated that the lutetium-177 RLT commercial model can scale, and a number of companies are now pursuing pipeline candidates across multiple tumour types. Curium's own late-stage pipeline includes a prostate cancer programme, suggesting BEXLUTRY is intended as a platform entry rather than a one-indication product.

From a regulatory standpoint, the 505(b)(2) route taken here offers an instructive precedent for other radiopharmaceutical developers seeking to enter established indications without repeating the full originator trial package. The FDA's willingness to accept bridging data for radiopharmaceutical equivalents, where physical and chemical characterisation is highly specific, may accelerate future competition in the lutetium-177 space.

Renaud Dehareng, Curium's Group Chief Executive, said the approval represents the company bringing "the full diagnosis-to-therapy capability needed to scale theranostics responsibly," reflecting the dual diagnostic-therapeutic model that underpins the theranostics investment case.

BEXLUTRY is now available for prescribing in the United States. Curium has indicated its immediate focus is on a quality-controlled commercial launch supported by its nuclear medicine infrastructure, with emphasis on scheduling predictability for treatment sites and consistent patient access.

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