KENILWORTH (NJ) (dpa-AFX) - Drug major Merck & Co., Inc. (MRK) announced Friday that its WELIREG (belzutifan) has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP, which recommended the conditional approval in two indications.
WELIREG, Merck's oral hypoxia-inducible factor-2 alpha (HIF-2?) inhibitor, has been recommended as monotherapy for the treatment of adult patients with certain types of Von Hippel-Lindau or VHL disease-associated tumors, as well as for certain previously treated adult patients with advanced renal cell carcinoma.
The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the first quarter of 2025.
If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2?) inhibitor available for these patients in the European Union.
The adult patients with VHL disease include those who require therapy for associated, localized renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, and for whom localized procedures are unsuitable.
Further, WELIREG has been recommended to treat adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies.
The positive opinion granted was based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial
The CHMP recommendation in VHL disease-associated tumors is based on objective response rate and duration of response results from the LITESPARK-004 trial.
If approved, WELIREG would be the first and only systemic treatment for patients with VHL disease-associated tumors in the EU.
In August 2021, WELIREG was approved in the U.S. to treat adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas or pNET.
For adult patients with advanced RCC, the drug was approved in the U.S. in December 2023.
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