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
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.
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.
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) [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.