FDA approves Merck’s Welireg for treatment of patients with advanced RCC

Merck announced that the U.S. Food and Drug Administration has approved WELIREG, an oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor. The approval is based on statistically significant and clinically meaningful results from LITESPARK-005, which is the only trial in advanced RCC to specifically evaluate patients who have progressed following a PD-1 or PD-L1 inhibitor and a VEGF-TKI. In the trial, WELIREG demonstrated superior progression-free survival versus everolimus in advanced RCC following treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, given in sequence or in combination.