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Merck's Welireg Recommended for Conditional Approval by European Medicines Agency
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Merck's Welireg Recommended for Conditional Approval by European Medicines Agency
Dec 13, 2024 5:28 AM

08:05 AM EST, 12/13/2024 (MT Newswires) -- Merck ( MRK ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended conditional approval of its experimental drug, Welireg, to treat certain adult patients with von Hippel-Lindau disease-associated Tumors and certain patients with advanced renal cell carcinoma.

The company said it also recommended for adult patients with advanced clear cell renal cell carcinoma that has progressed following two or more lines of therapy, including a PD-1 or PD-L1 inhibitor and at least two vascular endothelial growth factor targeted therapies.

It added that the recommendation was based on the results from the trial, which showed positive outcomes in objective response rate and duration of response in von Hippel-Lindau-associated tumors.

It added that the European Commission will now review it, with a final decision expected in Q1 2025.

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