By Fineline Cube 
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that the US Food & Drug Administration (FDA) has approved a new indication for its anti – PD – 1 therapy Keytruda (pembrolizumab).The drug is now approved for the perioperative treatment of resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD – L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA – approved test. It can be used as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
Approval Based on Key Clinical Trial
The approval is supported by data from the Phase III KEYNOTE – 689 trial. The trial showed a 30% reduction in risk of EFS events (disease recurrence/progression or death) vs standard adjuvant therapy. In PD – L1 CPS ≥1 patients, the median EFS was 59.7 months for Keytruda compared with 29.6 months for standard of care (SOC).
Significance and Market Implications
This new indication marks a significant step forward in the treatment landscape for HNSCC. It provides an option for patients whose tumors meet the PD – L1 expression criteria, potentially improving outcomes and offering a comprehensive treatment approach from the perioperative stage through adjuvant therapy.-Fineline Info & Tech