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# FDA OKs Merck Kidney Cancer Drug
- URL: https://www.fdaweb.com/fda-oks-merck-kidney-cancer-drug/
- Published: 2023-12-17T12:00:00.000Z
- Updated: 2026-09-14T14:18:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156004

FDA has approved a Merck NDA for Welireg (belzutifan) for treating patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Approval was based on data from the LITESPARK-005 (NCT04195750 head-to-head trial of 746 patients with unresectable locally advanced or metastatic clear cell RCC that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI, an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “A statistically significant improvement in PFS \[progression-free survival\] was demonstrated for belzutifan compared with everolimus,” it says. “While OS \[overall survival\] results were immature at the current analysis, with 59% of deaths reported, no trend towards a detriment was observed. A descriptive analysis of patient-reported symptom and functional outcomes was supportive of improved tolerability for belzutifan compared to everolimus.”

Regarding safety, FDA says the most common adverse reactions (greater than 25% incidence) in patients receiving belzutifan were decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.