FDA approves Welireg with Keytruda or Keytruda Qlex for adjuvant clear cell kidney cancer

The FDA approved Welireg (belzutifan) in combination with Keytruda or Keytruda Qlex for adjuvant treatment of adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy. The approval follows the LITESPARK-022 trial, where the combination cut the risk of recurrence, metastasis or death by 28%. It is the first earlier-stage approval for Welireg and the first approval of a PD-1 plus HIF-2 alpha inhibitor combination.

• Approval date: June 12, 2026
• Covers Keytruda and Keytruda Qlex combinations
• Hazard ratio 0.72 versus Keytruda plus placebo
• First earlier-stage label for Welireg