Merck's KEYTRUDA Approved in EU for Treating Resectable LA-HNSCC

29 October 2025

Key highlights

KEYTRUDA is approved for neoadjuvant and adjuvant treatment in LA-HNSCC.
The approval is based on results from the KEYNOTE-689 study.
It is the first anti-PD-1 option for LA-HNSCC in the EU.
Treatment involves radiation therapy with or without cisplatin.

Approval Overview

The European Commission has approved KEYTRUDA (pembrolizumab) for treating resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. This approval is specific to tumors expressing PD-L1 with a Combined Positive Score (CPS) ≥1.

Treatment Regimen

KEYTRUDA is approved as a neoadjuvant treatment, followed by adjuvant treatment in combination with radiation therapy, with or without concomitant cisplatin, and then as monotherapy.

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Significance

This marks the first and only anti-PD-1 treatment option for resectable LA-HNSCC in the European Union, based on the results of the KEYNOTE-689 study.