FDA accepts for priority review sNDA for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for Welireg, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2alfa) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies.
The sNDA is based on data from the LITESPARK-005 trial, in which Welireg demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee. A statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) was also demonstrated.
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 17, 2024.
Welireg was the first HIF-2alfa inhibitor therapy approved in the U.S. and is currently approved for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
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