Pharmaceutical Executive December 15, 2023
Pharmaceutical Executive Editorial Staff

Welireg (belzutifan) approved for the treatment of adults with advanced renal cell carcinoma that progressed after a regimen of a PD-1 or PD-L1 inhibitor and a VEGF-TKI.

The FDA has approved Merck’s Welireg (belzutifan) for the treatment of adults with advanced renal cell carcinoma (RCC) that progressed after a regimen of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).1 Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, was previously granted priority review by the FDA.2

“Despite recent progress in the treatment of advanced RCC, there is yet to be an option specifically approved for patients whose disease progresses following a PD-1 or PD-L1 inhibitor and a TKI...

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