> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck Touts Welireg in Kidney Cancer
- URL: https://www.fdaweb.com/merck-touts-welireg-in-kidney-cancer/
- Published: 2023-08-18T12:00:00.000Z
- Updated: 2026-09-14T18:51:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155134

Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating adults with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor therapies. The oral hypoxia-inducible factor-2 alpha inhibitor is currently approved for treating adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors.

“In the trial, Welireg showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus, based on a pre-specified interim analysis conducted by an independent data monitoring committee,” Merck says. A statistically significant improvement in the trial’s key secondary endpoint (objective response rate) was also shown, it says. The company says it also showed a “trend toward improvement in overall survival,” but this did not reach statistical significance. The drug’s safety profile in the trial was consistent with previously reported studies.