Merck's Keytruda Secures FDA Nod For Head And Neck Cancer As First Immunotherapy For Use Around Surgery

The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), 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.

The approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1).

The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial.

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At the trial’s ...