Lutetium-177 dotatate (radioligand equivalent)
A second, cheaper version of an already-approved radioactive drug for neuroendocrine tumours has been approved, using the same active radioactive ingredient as the original but made by a different company.
Overview
Bexlutry (lutetium Lu 177 dotatate injection), from Curium, is the first product the FDA has approved as a 'radioligand equivalent' of an existing radiopharmaceutical: it has the same active radiopharmaceutical ingredient as Novartis/Advanced Accelerator Applications' Lutathera. The FDA approved it on 14 September 2026 for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), spanning foregut, midgut and hindgut tumours.
Curium filed under the FDA's 505(b)(2) pathway in July 2024, relying on published evidence and bridging data demonstrating a similar biological and chemical profile to Lutathera rather than running a new phase 3 trial. Approval followed a June 2026 court decision that cleared Curium of patent-infringement claims brought by Novartis. Unlike Lutathera, whose US label also covers paediatric patients aged 12 and older, Bexlutry's approval is adult-only.
Bexlutry is immediately available for prescribing in the US. A second lutetium dotatate candidate, Lantheus's PNT2003, received FDA tentative approval in March 2026 under the abbreviated new drug application (ANDA) pathway but is not yet launched; separately, ITM's related product 177Lu-edotreotide (ITM-11) received an FDA complete response letter in August 2026 over manufacturing and third-party facility issues unrelated to its clinical data. Bexlutry's approval is the first time a radioligand therapy for cancer has faced this kind of direct, lower-cost competition in the US market.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
PubChem holds the unlabelled ligand, so the radionuclide itself is not in this drawing.
A somatostatin analogue (DOTATATE) labelled with beta-emitting lutetium-177, delivering targeted radiation to somatostatin receptor-positive neuroendocrine tumour cells; chemically and biologically the same active ingredient as Lutathera, approved through the FDA's 505(b)(2) route as a radioligand equivalent rather than through a new pivotal efficacy trial. Connects to Somatostatin receptor 2.
- PSMA / SSTR-positive cell
1.Lutetium-177 dotatate (radioligand equivalent) binds Somatostatin receptor 2 on the cancer cell or is taken up by it.
- 14 Sept 2026ApprovalUS
Bexlutry, NDA 218525 (Curium), original approval; FDA classification Type 5 new formulation or new manufacturer, standard review source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut and hindgut tumours, in adults · Approved via the FDA 505(b)(2) pathway as a radioligand equivalent of Lutathera, 14 September 2026 |
Trials
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Latest papers
topQuery for this drug: (TITLE:"Lutetium-177 dotatate" OR ABSTRACT:"Lutetium-177 dotatate" OR TITLE:"radioligand equivalent" OR ABSTRACT:"radioligand equivalent" OR TITLE:"Bexlutry" OR ABSTRACT:"Bexlutry" OR TITLE:"generic lutetium Lu 177 dotatate" OR ABSTRACT:"generic lutetium Lu 177 dotatate") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lutetium-177 dotatate (radioligand equivalent), not a curated reading list.
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