Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Pembrolizumab in patients with Head and Neck Squamous Cell Carcinoma.
The U.S. Food and Drug Administration granted approval to pembrolizumab for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an FDA-approved test.