FDA Extends Approval of Immunotherapy Agent Keytruda® to Include Esophageal Cancer

The U.S. Food and Drug Administration (FDA) approved the immunotherapy agent Keytruda® (pembrolizumab) as monotherapy for the treatment of recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) in patients whose tumors express PD-L1 and have experienced disease progression after one or more prior lines of systemic therapy. The FDA also approved a new use for the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic device for selecting patients for this treatment.