FDA accepts sBLA for Keytruda

Keytruda/chemo combo approved for NSCLC on NHS

Merck’s new supplemental Biologics License Application (sBLA) for Keytruda as a first-line treatment in combination with chemotherapy for head and neck squamous cell carcinoma (HNSCC) has been accepted by the FDA.

The sBLA is based in part on data from the pivotal Phase 3 KEYNOTE-048 trial where Keytruda demonstrated a significant improvement in overall survival compared with the standard of care.

“Head and neck cancer remains a challenging and devastating disease, and newly diagnosed patients are in need of improved treatment options,” said Dr Jonathan Cheng, Vice President, Clinical Research, Merck Research Laboratories.

“Merck continues to make meaningful advances in the treatment of head and neck cancer, and we look forward to working with the FDA to bring these important new options to patients in the first-line setting.”