# Lutetium (177Lu) oxodotreotide

Lutetium (177Lu) oxodotreotide (Lutathera, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: Somatostatin receptor (1).

## Approved indications

### Neuroendocrine tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Somatostatin receptor-positive | Monotherapy | Advanced | Gastroenteropancreatic NET only; Progressive; well-differentiated (G1 and G2) |

## Products

### Lutathera

- Company: Novartis Europharm Limited
- Target: SSTR2-targeted radioligand
- ATC: V10XX04
- EU approval: 26 Sep 2017
- Label revised: 14 Aug 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lutathera-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lutathera

Mechanism (SmPC section 5.1): Binds to subtype 2 somatostatin receptors on tumour cells and delivers beta-minus radiation to cause targeted cell death.

## Label wording

- **Lutetium (177Lu) oxodotreotide** (Lutathera), Neuroendocrine tumours, advanced: “Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/lutetium-177lu-oxodotreotide