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Regeneron Pharmaceuticals Gets European Commission's Approval for Expanded Indication for Libtayo
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Regeneron Pharmaceuticals Gets European Commission's Approval for Expanded Indication for Libtayo
Nov 19, 2025 6:21 AM

08:32 AM EST, 11/19/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Wednesday it has received the European Commission's approval for its PD-1 inhibitor Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma.

The approval expands the existing EU indication for Libtayo to include patients at high risk of disease recurrence after surgery and radiation, the company said.

The approval is supported by data from a global phase 3 trial showing that Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared with placebo, Regeneron said.

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