Merck and Eisai have won U.S. Food and Drug Administration approval of the dual oral regimen of Merck's Welireg plus both companies' Lenvima in certain patients with the most common type of kidney cancer.
The companies on Friday said the green light covers the combination in adults with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
Welireg plus Lenvima is the first approved combination of a hypoxia-inducible factor-2 alpha inhibitor and a multi-targeted vascular endothelial growth factor receptor tyrosine kinase inhibitors for these patients, the companies said.
Rahway, N.J., drugmaker Merck and Tokyo-based Eisai formed a collaboration in 2018 to jointly develop, manufacture and commercialize Lenvima, which Eisai discovered.