The FDA approved a new indication for pembrolizumab (Keytruda, Merck)—monotherapy for patients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
The approval was based on data from KEYNOTE-181, a multicenter, randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally