Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. The application seeks approval for Keytruda’s use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, followed by adjuvant therapy in combination with standard radiotherapy with or without cisplatin, and then as a single agent. The FDA is expected to make a decision by June 23, 2025.
Study Results
The sBLA is supported by data from the Phase III KEYNOTE-689 study. A pre-specified first interim analysis showed that Keytruda’s perioperative regimen significantly improved event-free survival (EFS) compared to adjuvant radiotherapy alone. The study also demonstrated a significant improvement in major pathological response (mPR) in the Keytruda arm versus radiotherapy alone. Safety data were consistent with previous studies, with no new safety signals.
Current Approvals
Keytruda is currently approved as monotherapy and in combination regimens for metastatic or unresectable, recurrent HNSCC in the US, Europe, China, Japan, and other regions. The potential new indication aims to expand treatment options for resectable LA-HNSCC patients.-Fineline Info & Tech
