Merck’s application for keytruda in HNSCC granted priority review by FDA

Merck (MRK) announced the FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for keytruda – pembrolizumab -, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma, or 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 target action date of June 23. The sBLA is based on data from the Phase 3 trial which 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 compared to adjuvant radiotherapy alone. The study also showed a statistically significant improvement in major pathological response, a key secondary endpoint, for patients in the keytruda arm compared with adjuvant radiotherapy alone. No new safety signals were identified.