Merck & Co. Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) as the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS ≥1). This approval introduces a new treatment paradigm, providing a significant advancement in the care of patients with this condition. The approval was reviewed under Project Orbis, an FDA Oncology Center of Excellence initiative that allows for simultaneous review of oncology drugs by international partners. Concurrently, marketing authorization applications based on the results of KEYNOTE-689 are under review in several countries, including Israel, Canada, Australia, Singapore, Brazil, and Switzerland, as well as by regulatory authorities in Europe and Japan.