FDA approves Curium's Bexlutry as first radioligand equivalent for SSTR-positive GEP-NETs
The FDA has approved Curium's Bexlutry as the first radioligand equivalent to Lutathera for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours.
Bexlutry, or lutetium Lu 177 dotatate, delivers targeted radiation to tumour cells expressing somatostatin receptors and provides a new radioligand treatment option for eligible patients with GEP-NETs.
The approval introduces the first FDA-approved therapeutic equivalent to Novartis' Lutathera and could broaden access to radioligand therapy in neuroendocrine tumour care.
Field | Content |
Alert Type | Approval |
Drug Name | Lutetium Lu 177 dotatate |
Brand Name | Bexlutry |
Company | Curium Pharma |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | New drug approval; radioligand therapeutic equivalent |
Indication | Treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours |
Therapy Area(s) | Oncology; neuroendocrine tumours |
Technology or Modality | Radioligand therapy |
Reference Product | Lutathera |
Geography | United States |
What Happened | The FDA approved Bexlutry (lutetium Lu 177 dotatate) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. |
Why It Matters | Bexlutry is the first FDA-approved radioligand therapeutic equivalent to Lutathera, introducing another treatment option in an increasingly important precision-oncology modality. |
Supporting Context | Lutetium Lu 177 dotatate targets somatostatin receptor-expressing tumour cells and delivers radioactive lutetium-177 directly to those cells. |
Key Takeaway | Bexlutry becomes the first FDA-approved Lutathera equivalent for SSTR-positive GEP-NETs. |
What to Watch | Commercial rollout, treatment-centre adoption and the effect of additional competition on access to radioligand therapy. |
Primary Source | Curium Pharma |
Relevant Date | 14 September 2026 |
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