Therapeutic Response

PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Pembrolizumab in patients with Head and Neck Squamous Cell Carcinoma.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA.

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.
Keytruda (pembrolizumab) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to pembrolizumab as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin, and then as a single agent for the treatment of adult patients with resectable locally advanced head and neck squamous cell cancer (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) >= 1], as determined by an FDA-approved test.
Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a monotherapy treatment option for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a CPS >= 1.
Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a monotherapy treatment option for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a CPS >= 1.
Keytruda (pembrolizumab) [product information]. EMA.

The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score (CPS) >= 1.