# Lutetium-177 dotatate (radioligand equivalent)

Source: https://nuclide.cc/drugs/lu-177-dotatate-generic/  
Nuclide record `lu-177-dotatate-generic` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Agent
- Status: approved
- Last checked: 2026-09-27
- Also known as: Bexlutry; generic lutetium Lu 177 dotatate
- Tags: radioligand therapy; generic; neuroendocrine tumours; beta emitter
- Brand: Bexlutry
- Modality: radioligand therapy
- Mechanism: 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.
- Approvals: US 2026: Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut and hindgut tumours, in adults

## Sources

- Drugs@FDA: NDA 218525, Bexlutry (lutetium Lu 177 dotatate): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218525
- Curium: FDA approval of BEXLUTRY, 14 September 2026: https://www.curiumpharma.com/2026/09/14/fda-approval-bexlutry/
- FiercePharma: FDA approves first radioligand equivalent: https://www.fiercepharma.com/pharma/fda-approves-first-radioligand-equivalent-curiums-copycat-novartis-lutathera
- MedPath: FDA approves Curium's Bexlutry, first generic radioligand: https://trial.medpath.com/news/fda-approves-curium-s-bexlutry-first-generic-radioligand-challenging-lutathera-s-gep-net-monopoly

## Connected records

- drugs: [177Lu-edotreotide](https://nuclide.cc/drugs/itm-11/), [Lutetium-177 dotatate](https://nuclide.cc/drugs/lutathera/)
- isotopes: [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://nuclide.cc/indications/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://nuclide.cc/indications/small-intestinal-net/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://nuclide.cc/technologies/prrt/), [Radioligand therapy (beta emitters)](https://nuclide.cc/technologies/radioligand-therapy/)
- targets: [Somatostatin receptor 2](https://nuclide.cc/targets/sstr2/)
- companies: [Curium](https://nuclide.cc/companies/curium/)

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