On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 as determined by an FDA-approved test. Keytruda® is approved as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent. The approval comes in advance of the 23 June 2025 target action date assigned when the sBLA was accepted by the FDA for priority review in February 2025.
The FDA’s review of MSD’s sBLA was conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners. Keytruda® is currently under evaluation in Australia for the same HNSCC indication and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.
The new indication approval comes days after it was reported by Fierce Pharma that the FDA has narrowed the label for Keytruda® (and Opdivo® (nivolumab)) in gastric, gastroesophageal junction and oesophageal cancers to only those patients whose tumours express PD-L1. The limitation for Keytruda® applies to HER2-negative disease as the indication relating to HER2-positive disease had already been limited to PD-L1 positive tumours in November 2023.