Posted by Michael Wonder on 12 Jun 2025
FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA approved test, as a single agent as neo-adjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent.
This is the first approval for head and neck squamous cell carcinoma in 6 years and the first overall peri-operative approval for locally advanced head and neck squamous cell carcinoma.
