# Lutetium Lu 177 dotatate (PNT2003)

Source: https://onco.cc/drugs/pnt2003/  
OnCo record `pnt2003` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

PNT2003 is a generic version of Lutathera, the radioactive treatment for neuroendocrine tumours of the gut and pancreas. Lantheus licensed it from POINT Biopharma and received tentative FDA approval in March 2026; full approval was waiting on a patent dispute.

## Summary

PNT2003 is lutetium Lu 177 dotatate made as a radioequivalent version of Lutathera, which is indicated for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. Lantheus licensed exclusive worldwide rights (excluding certain territories) from POINT Biopharma in December 2022; Eli Lilly later acquired POINT. On 2 March 2026 Lantheus announced FDA tentative approval of its abbreviated new drug application, meaning the FDA had completed its review, with full approval subject to the end of a 30-month stay in June 2026 triggered by Hatch-Waxman patent litigation. Whether full approval or launch has followed was not confirmed in the sources read, so the record does not mark it approved.

## Fields

- Kind: Treatment
- Status: emerging
- Last checked: 2026-11-03
- Also known as: PNT2003; 177Lu-PNT2003
- Tags: pipeline; deal-asset
- Code: PNT2003
- Modality: Radioligand therapy (beta), generic radioequivalent of Lutathera
- Mechanism: A somatostatin-like peptide carrying radioactive lutetium-177 binds somatostatin receptors on neuroendocrine tumour cells and irradiates them from close range. It is intended as a radioequivalent version of Lutathera, whose US label says it binds somatostatin receptors with highest affinity for subtype 2 (SSTR2).

## Sources

- Lantheus: FDA tentative approval for PNT2003, 2 March 2026 (BioSpace copy): https://www.biospace.com/press-releases/lantheus-receives-fda-tentative-approval-for-lutetium-lu-177-dotatate-pnt2003-radioequivalent-to-lutathera
- Lutathera US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55

## Connected records

- drugs: [Lutetium-177 dotatate](https://onco.cc/drugs/lutathera/)
- cancers: [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/)
- technologies: [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- targets: [Somatostatin receptor 2](https://onco.cc/targets/sstr2/)
- companies: [Lantheus](https://onco.cc/companies/lantheus/), [POINT Biopharma](https://onco.cc/companies/point-biopharma/)

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JSON: https://onco.cc/api/v1/entities/pnt2003.json