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 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.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS >= 1.