Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus standard of care as peri-operative treatment for resectable locally advanced head and neck squamous cell carcinoma
25 February 2025 - Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement in event-free survival in the neo-adjuvant and adjuvant setting for an anti-PD-1 therapy in earlier stages of head and neck squamous cell carcinoma.
Merck today announced the US FDA has accepted for priority review a new supplemental biologics license application seeking approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma as neo-adjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent.
