Posted by Michael Wonder on 19 Sep 2023
FDA accepts for priority review Merck’s supplemental new drug application for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma
19 September 2023 - Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced renal cell carcinoma that progressed following PD-1/L1 and VEGF-TKI therapies.
Merck today announced the US FDA has accepted and granted priority review for a supplemental new drug application seeking approval for Welireg, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies.
