Welireg (belzutifan)
- Region
- 🇪🇺 EU
- Active substance
- belzutifan
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Renal Cell; von Hippel-Lindau Disease
- CHMP opinion
- Thu 12 Dec 2024
- EU approval
- Wed 12 Feb 2025
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005636
- ATC
- L01XX74
- Official record
- www.ema.europa.eu
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), and for whom localised procedures are unsuitable.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.