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Regeneron Says its Libtayo Adjuvant Treatment for Cutaneous Squamous Cell Carcinoma Recommended for EU Approval
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Regeneron Says its Libtayo Adjuvant Treatment for Cutaneous Squamous Cell Carcinoma Recommended for EU Approval
Oct 17, 2025 5:22 AM

08:11 AM EDT, 10/17/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Friday that Libtayo, an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation, has been recommended for EU approval by the European Medicines Agency's Committee for Medicinal Products for Human Use.

The European Commission is expected to make a final decision on the application for the drug in the coming months, the company said.

The agency's positive opinion is supported by results from the drug's global phase 3 trial, which showed that Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo, Regeneron said.

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