Merck & Co., Inc. — Welireg EMA EPAR public assessment report (EMEA/H/C/005636, 2025)

Merck & Co., Inc. · 2025 · EMA EPAR public assessment report · company profile →

Report summary

This report summarizes the EMA's assessment of Merck's Welireg (belzutifan) for advanced renal cell carcinoma (RCC) and von Hippel-Lindau (VHL) disease-associated tumors. Belzutifan, an HIF-2α inhibitor, addresses unmet needs in these conditions. Preclinical and clinical studies demonstrate its efficacy, particularly a 63.9-67.2% objective response rate in VHL-associated RCC and durable responses in other VHL tumors. In advanced RCC, it showed a PFS benefit (HR 0.73) over everolimus, but no significant OS benefit at interim analysis. Common adverse events include anemia and hypoxia, which are manageable. The report details pharmacokinetics, safety profiles, and risk management plans, supporting conditional marketing authorization.

Key findings — cited to the page

incidence of anaemia ≥Grade 3	25 %	MK-6482-005 (Q2 AUCavg) · p.69
incidence of anaemia all grades	75 %	MK-6482-005 (Q1 AUCavg) · p.69
median time to onset of hypoxia ≥Grade 3	4.14 weeks	Study 005 · p.69
incidence of anaemia ≥Grade 3	20 %	MK-6482-005 (Q1 AUCavg) · p.69
incidence of anaemia ≥Grade 3	46 %	MK-6482-005 (Q4 AUCavg) · p.69
incidence of anaemia ≥Grade 3	33 %	MK-6482-005 (Total N=379) · p.69
incidence of anaemia all grades	84 %	MK-6482-005 (Q4 AUCavg) · p.69
median time to onset of anaemia ≥Grade 3	4.14 weeks	Study 005 · p.69
median time to onset of all grades anaemia	4.14 weeks	Study 005 · p.69
median time to onset of all grades hypoxia	4.21 weeks	Study 005 · p.69
incidence of anaemia ≥Grade 3	34 %	MK-6482-005 (Q3 AUCavg) · p.69
incidence of anaemia all grades	79 %	MK-6482-005 (Q2 AUCavg) · p.69

Source: Merck & Co., Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →