Belzutifan Market

The Belzutifan market is witnessing a CAGR of 5.6% during the forecast period of 2025-2035. Belzutifan, sold as WELIREG®, is an oral inhibitor of hypoxia-inducible factor-2 alpha (HIF-2α) that has been developed for the treatment of particular cancers, such as advanced renal cell carcinoma (RCC) and tumors that are part of von Hippel-Lindau (VHL) disease. Its regulatory agency approval, such as that of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), emphasizes its therapeutic relevance.

In the US, belzutifan was approved in adult patients with advanced RCC following other therapies, including a PD-1 or PD-L1 inhibitor and a VEGF-TKI. The approval was supported by the LITESPARK-005 trial, showing a statistically significant increase in progression-free survival in patients treated with belzutifan versus everolimus. The recommended dose is 120 mg oral daily until disease progression or unacceptable toxicity.

In the EU, EMA has also recommended granting conditional marketing authorization for WELIREG® to treat adult patients with advanced clear cell RCC that progressed despite two or more prior treatments, including a PD-(L)1 inhibitor and at least two classes of VEGF-targeted therapies. It is also used in adults with VHL disease who need treatment for related, localized RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, and for whom local treatment is not appropriate. The EMA decision is supported by clinical trials confirming the effectiveness of belzutifan to shrink and slow down tumor growth.