FDA Approves Welireg With Pembrolizumab for Renal Cell Carcinoma

THURSDAY, June 18, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has approved Welireg (belzutifan) in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the adjuvant treatment of renal cell carcinoma in adults with a clear cell component at intermediate-high or high risk for recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.Welireg includes a boxed warning for embryo-fetal toxicity and warnings and precautions for anemia and hypoxia. Pembrolizumab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.The approval is based on results from LITESPARK-022, a phase 3 clinical trial that took place at 285 sites around the world. At a median follow-up of 28.4 months, results showed that the combination reduced the risk for disease recurrence by 28 percent compared with pembrolizumab with a placebo. For disease-free survival (DFS), results showed a statistically significant improvement at a prespecified interim analysis (186 events in the Welireg with pembrolizumab group and 246 events in the placebo with pembrolizumab group). Neither group achieved median DFS."This trial showed an advance over pembrolizumab monotherapy in this setting, but overall survival was immature at the time of analysis," Hans Hammers, M.D., Ph.D., who led the trial at UT Southwestern Medical Center in Dallas, said in a statement.Approval of Welireg was granted to Merck.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Welireg With Pembrolizumab for Renal Cell Carcinoma

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