Merck announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for the conditional approval of Welireg (belzutifan), an oral HIF-2α inhibitor.

The drug is recommended as monotherapy to treat adults with von Hippel-Lindau disease (VHL) requiring management for localized renal cell carcinoma, central nervous system hemangioblastoma or pancreatic neuroendocrine tumors, as well as adults with renal cell carcinoma.

The recommendation is based on the results of two trials, the company says.

If approved, Welireg would become the first systemic treatment for VHL-associated tumors in the EU.

A decision by the European Commission is expected in the first quarter of 2025.

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