Merck’s Welireg (belzutifan) combined with Keytruda (pembrolizumab) won FDA approval for an adjuvant setting in clear cell renal cell carcinoma (ccRCC), aiming to reduce recurrence risk after kidney removal surgery. The approval follows the company’s Litespark-022 trial showing a 28% reduction in risk of disease recurrence, metastasis, or death versus Keytruda plus placebo. The FDA action expands the role of the HIF-2α inhibitor beyond Merck’s earlier advanced RCC indication. Notably, overall survival data are not yet mature, but Merck and study leaders framed disease-free survival as clinically meaningful for earlier-stage patients facing high recurrence risk. The regimen is described as usable with standard Keytruda dosing (including subcutaneous Keytruda Qlex) in intermediate-high or high-risk adult patients, positioning Welireg–Keytruda as a new post-surgical standard candidate in ccRCC where durability remains a key unmet need.