FDA Approves Merck’s Welireg for Expanded Use in Kidney Cancer, Boosting Sales Prospects

Merck’s cancer drug Welireg (belzutifan), approved in August 2021, has been making steady sales progress. Recently, it received a second FDA approval for a larger patient group, expected to boost its revenue significantly. Welireg, a hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, is now approved for treating relapsed or refractory renal cell carcinoma (RCC) in adults who have not responded to a PD-1 or PD-L1 inhibitor and have been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1).

This marks Welireg as the first drug for advanced RCC patients and the first novel-class treatment for this indication since 2015. Initially, Welireg was approved for treating von Hippel-Lindau disease, a hereditary condition leading to tumors in various organs, primarily the kidneys. RCC is the most common form of kidney cancer, comprising about 90% of cases.

In a phase 3 study, Welireg outperformed Novartis’ Afinitor, showing higher rates of progression-free survival and objective response. Merck aims to expand Welireg’s use in RCC, investigating its effectiveness in earlier treatment stages. Sales of Welireg have been rising, reaching $54 million in recent quarters, with analysts estimating its peak sales potential between $1 billion and $1.5 billion if approved for earlier-stage RCC patients.

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[Source: Fierce Pharma, December 15th, 2023]