The European Commission gave its nod to Merck’s Keytruda as a monotherapy or in combination with chemotherapy for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.

The approval was based on the results of a phase 3 clinical trial, in which the drug demonstrated a significant improvement in overall survival as a monotherapy and in combination with chemotherapy compared to standard treatment.

The approval makes Keytruda the first anti-PD-1 treatment option as a first-line treatment for metastatic or unresectable recurrent head and neck cancer.