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Merck's Keytruda Wins EU Approval for First-Line Head and Neck Cancer Regimen
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Merck's Keytruda Wins EU Approval for First-Line Head and Neck Cancer Regimen
Oct 29, 2025 7:42 AM

10:19 AM EDT, 10/29/2025 (MT Newswires) -- Merck ( MRK ) received European Commission approval for its anti-PD-1 therapy Keytruda as part of a treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma.

The approval applies to patients whose tumors express PD-L1 with a combined positive score of greater than or equal to 1, the company said Wednesday in a statement. Keytruda is authorized as neoadjuvant monotherapy, followed by adjuvant treatment in combination with radiotherapy, with or without cisplatin, and then continued as monotherapy,

This marks the first and only anti-PD-1 treatment approved in the EU for this patient population, the company said. The approval was based on results from a Phase 3 trial, which showed the Keytruda-based regimen reduced the risk of disease recurrence.

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