FDA Approves Neoadjuvant and Adjuvant Keytruda for Resectable, Locally Advanced Head and Neck SCC

The FDA has approved pembrolizumab (Keytruda, Merck) for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death ligand-1 (PD-L1) (Combined Positive Score [CPS] ≥1), as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.

This is the first approval for HNSCC in