# Belzutifan

Belzutifan (Welireg, Merck Sharp & Dohme B.V.) has 4 EU-approved indications in 3 tumour types.

## Approved indications

### Neuroendocrine tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Early | Pancreatic NET only; Von Hippel-Lindau disease; localised procedures are unsuitable |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+, advanced | Clear cell only; Progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies |
| None | Monotherapy | Early | Von Hippel-Lindau disease; localised procedures are unsuitable |

### Other CNS tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Early | Von Hippel-Lindau disease; localised procedures are unsuitable |

## Products

### Welireg

- Company: Merck Sharp & Dohme B.V.
- Target: HIF-2α inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX74
- EU approval: 12 Feb 2025
- Label revised: 14 Oct 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/welireg-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/welireg

Mechanism (SmPC section 5.1): Belzutifan binds HIF-2α and blocks its interaction with HIF-1β, reducing transcription and expression of HIF-2α target genes linked to proliferation, angiogenesis and tumour growth.

## Label wording

- **Belzutifan** (Welireg), Renal cell carcinoma, 3rd line+, advanced: “WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf)
- **Belzutifan** (Welireg), Renal cell carcinoma, 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)
- **Belzutifan** (Welireg), Other CNS 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)
- **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)

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/belzutifan