FDA Approval Alert: The Need-to-Know | Perioperative Pembrolizumab Plus Radiation in Locally Advanced HNSCC

In June 2025, the FDA approved neoadjuvant pembrolizumab monotherapy followed by adjuvant pembrolizumab plus radiotherapy with or without cisplatin after surgery and then pembrolizumab monotherapy among patients with PD-L1–positive locally advanced head and neck squamous cell carcinoma.

Data from the phase 3 KEYNOTE-689 trial support the approval of the pembrolizumab-based regimen in this locally advanced HNSCC population.
FDA Approves Perioperative Pembrolizumab Plus Radiation in HNSCC
Article
Jun 12, 2025 10:40 PM
Data from the phase 3 KEYNOTE-689 trial support the approval of the pembrolizumab-based regimen in this locally advanced HNSCC population.