07:18 AM EDT, 06/13/2025 (MT Newswires) -- Merck ( MRK ) said Friday that the US Food and Drug Administration HAS approved Keytruda for adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1.

The company said Keytruda was approved as a neoadjuvant therapy, continued post-surgery with radiotherapy with or without cisplatin, followed by Keytruda alone.

The drugmaker said the approval was based on a phase 3 trial showing a 30% reduction in the risk of disease recurrence, disease progression, or death, compared with standard of care.

Marketing applications are also under review by regulatory authorities worldwide, including Europe and Japan, the company added.