FDA Approves Merck's Drug Belzutifan For Type Of Advanced Kidney Cancer In Pretreated Cancer Patients

The FDA approved Merck & Co Inc's MRK Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for adult patients with advanced renal cell carcinoma (RCC) following 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).

The approval marks the first time a new treatment has been approved in a novel therapeutic class in advanced RCC since 2015.

The approval is based on statistically significant and clinically meaningful results from LITESPARK-005.

In the trial, WELIREG demonstrated superior progression-free survival (PFS) versus Novartis AG's NVS Afinitor (everolimus) in advanced RCC following treatment with a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, given in sequence or combination. 

Also, Welireg showed an objective response rate (ORR) of 22% versus 4% (n=13) for everolimus.

In the trial, Welireg reduced the risk of disease progression or death by 25% versus everolimus in these patients. 

Median PFS was 5.6 months for Welireg versus 5.6 months for everolimus. The ORR for Welireg was 22% (n=82), with a complete response (CR) rate of 3% (n=10) and a partial response (PR) rate of 19% (n=72), and the ORR for everolimus was 4% (n=13) (95% CI, 2-6), with no patients achieving a CR and a PR rate of 4% (n=13).

Price Action: MRK shares are up 0.58% at $106.49 during the premarket session on the last check Friday.