EMA — authorised 12 February 2025
- Application: EMEA/H/C/005636
- Marketing authorisation holder: Merck Sharp & Dohme B.V.
- Local brand name: Welireg
- Indication: 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),
- Pathway: conditional
- Status: approved
The EMA approved Welireg, developed by Merck Sharp & Dohme B.V., for the treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) that progressed after two or more lines of therapy. This includes a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. Additionally, Welireg is indicated for adult patients with von Hippel-Lindau disease who require therapy for associated localised RCC, CNS haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.