FDA grants priority review to Merck’s sBLA for Keytruda

The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) for a new indication.

US pharma giant Merck & Co (NYSE: MRK) is seeking authorization for its mega blockbuster ’s anti-PD-1 therapy for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-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 has set a Prescription Drug User Fee Act (PDUFA) date of June 23, 2025, for its decision.

Merck said that the sBLA is based on data from the Phase III KEYNOTE-689 trial. Results from a pre-specified first interim analysis, which will be presented at an upcoming medical meeting, showed that in patients with resectable LA-HNSCC, the Keytruda perioperative treatment regimen demonstrated a statistically significant and clinically-meaningful improvement in event-free survival (EFS) compared to adjuvant radiotherapy (with or without cisplatin) alone. The study also showed a statistically-significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the Keytruda arm compared with adjuvant radiotherapy alone. The safety profile of Keytruda was consistent with that observed in previously reported studies; no new safety signals were identified.