Merck Wins FDA Approval for Kidney Cancer Combo, Slashing Recurrence Risk

The FDA approved Merck’s Welireg (belzutifan) in combination with Keytruda (pembrolizumab) for adult patients with renal cell carcinoma (RCC). The treatment targets patients with clear cell RCC at intermediate-high or high risk of recurrence following a nephrectomy.

This decision marks the first regulatory approval for a combination of a PD-1 inhibitor and a HIF-2α inhibitor. The approval follows results from the Phase 3 LITESPARK-022 trial.

The combination therapy reduced the risk of disease recurrence, metastasis, or death by 28% compared to Keytruda alone. This label expansion moves Welireg into earlier-stage kidney cancer treatment, a central component of Merck’s drug strategy.