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In the context of Pembrolizumab & Head & Neck squamous cell carcinoma (HNSCC), pembrolizumab has received several approvals from the FDA for the treatment of Head & Neck Squamous Cell Carcinoma (HNSCC) under different conditions and settings:
2016 Accelerated Approval: Pembrolizumab was granted accelerated FDA approval for patients with recurrent or metastatic HNSCC who have experienced disease progression on or after platinum-containing chemotherapy.
2019 First-Line Approval: The FDA approved pembrolizumab for use as a first-line treatment in patients with metastatic or unresectable recurrent HNSCC. This approval is for monotherapy in patients whose tumors express PD-L1 with a Combined Positive Score (CPS) of ≥1, as determined by an FDA-approved test.
**Second-Line Treatment…