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# Welireg-Keytruda Combo OK’d as Adjuvant Kidney Cancer Therapy
- URL: https://www.fdaweb.com/welireg-keytruda-combo-okd-as-adjuvant-kidney-cancer-therapy/
- Published: 2026-06-12T12:00:00.000Z
- Updated: 2026-09-14T13:41:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161304

FDA has approved Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patients with renal cell carcinoma (RCC) at elevated risk of disease recurrence following surgery.

The approval expands the use of belzutifan beyond its existing indications and establishes a new adjuvant treatment option for adults with clear cell renal cell carcinoma (ccRCC) who are at intermediate-high or high risk of recurrence after nephrectomy, including patients who have undergone resection of metastatic lesions and have no evidence of disease, according to an agency release.

The agency also approved the regimen in combination with Keytruda Qlex, Merck's subcutaneous pembrolizumab formulation containing berahyaluronidase alfa-pmph.

FDA says the decision was based on results from the Phase 3 LITESPARK-022 trial, which enrolled 1,841 patients with clear cell RCC who had undergone nephrectomy and were considered at elevated risk for recurrence. Patients were randomized to receive either belzutifan plus pembrolizumab or placebo plus pembrolizumab following surgery.

At a prespecified interim analysis, the combination demonstrated a statistically significant improvement in disease-free survival, the study's primary endpoint, it says. Investigators reported 186 disease-free survival events in the belzutifan arm compared with 246 events in the control group, translating to a 28% reduction in the risk of recurrence, metastasis, or death.

Median disease-free survival had not yet been reached in either treatment arm at the time of the analysis, FDA says, adding that overall survival data remain immature.