On 25 February 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab). The sBLA is for patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy, with or without cisplatin, and then as a single agent. The FDA’s target action date is 23 June 2025.
The sBLA is based on results of the Phase 3 KEYNOTE 689 trial. According to MSD, an interim analysis shows that the results demonstrate significant improvement in event-free survival in the neoadjuvant and adjuvant setting for pembrolizumab in earlier stages of HNSCC.
The FDA review of the sBLA is being 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. Regulatory authorities in Australia, Brazil, Canada, Israel and Switzerland will also be reviewing the application.
Keytruda® is approved as monotherapy and in combination regimens for certain patients with metastatic or unresectable, recurrent HNSCC in countries including the US, Europe, China, Japan, Australia and New Zealand.