Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 50% 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 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1 with a tumor proportion score >= 50% and who have progressed on or after platinum-containing chemotherapy.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a >= 50% TPS and progressing on or after platinum -containing chemotherapy.