Belzutifan

Belzutifan (Welireg, Merck Sharp & Dohme B.V.) has 4 EU-approved indications in 3 tumour types.
Approved indications of Belzutifan
Biomarker requirementRegimenSettingConditions
Neuroendocrine tumours1
None
Monotherapy
Any line
early
Pancreatic NET only; Von Hippel-Lindau disease; localised procedures are unsuitable
Renal cell carcinoma2
None
Monotherapy
3L+
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
Any line
early
Von Hippel-Lindau disease; localised procedures are unsuitable
Other CNS tumours1
None
Monotherapy
Any line
early
Von Hippel-Lindau disease; localised procedures are unsuitable
Full text of section 4.1 (therapeutic indications)

Renal cell carcinoma (RCC) 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. von Hippel-Lindau (VHL) disease-associated tumours 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.

Label history

3 changes to the Welireg label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes