# Neuroendocrine tumours

The EU has approved 6 indications of 5 drugs in neuroendocrine tumours. 1 of them needs a biomarker result: Somatostatin receptor (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### Somatostatin receptor-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Lutetium (177Lu) oxodotreotide](https://oncolabels.com/drugs/lutetium-177lu-oxodotreotide) (Lutathera) | Somatostatin receptor-positive | Monotherapy | Advanced | Gastroenteropancreatic NET only; Progressive; well-differentiated (G1 and G2) |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | Monotherapy | 2nd line, advanced | Progressed following at least one prior systemic therapy other than somatostatin analogues |
| [Belzutifan](https://oncolabels.com/drugs/belzutifan) (Welireg) | None | Monotherapy | Early | Pancreatic NET only; Von Hippel-Lindau disease; localised procedures are unsuitable |
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Afinitor) | None | Monotherapy | Advanced | Pancreatic NET only; Well- or moderately-differentiated; progressive disease |
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Afinitor) | None | Monotherapy | Advanced | Gastrointestinal or lung NET only; Well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease Ambiguous in the label (tumour site): check the SmPC. |
| [Sunitinib](https://oncolabels.com/drugs/sunitinib) (Sutent) | None | Monotherapy | Advanced | Well-differentiated pancreatic NET only; Disease progression |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Everolimus** (Afinitor), Neuroendocrine tumours, advanced: “Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Neuroendocrine tumours, advanced: “Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Neuroendocrine tumours, 2nd line, advanced: “CABOMETYX is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Belzutifan** (Welireg), Neuroendocrine tumours, early: “WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf)
- **Sunitinib** (Sutent), Neuroendocrine tumours, advanced: “Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf)
- **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/tumours/neuroendocrine-tumours