FDA approves Merck’s Keytruda-Welireg combo as adjuvant treatment for clear cell renal cancer

Merck & Co., Inc.

Merck & Co., Inc.

MRK

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  • FDA cleared Merck’s Keytruda or Keytruda QLEX with Welireg for adjuvant treatment of intermediate-high or high-risk clear cell renal cell carcinoma.
  • Approval was supported by Phase 3 LITESPARK-022, showing a 28% reduction in recurrence, metastasis, or death versus Keytruda with placebo (HR 0.72).
  • Estimated 24-month disease-free survival was 81% for the combination versus 74% for the control arm.


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