ODAC Discussing Immune Checkpoint Inhibitors

The FDA Oncology Drugs Advisory Committee meets 9/26 to discuss the risk/benefit assessment of using immune checkpoint inhibitors (ICIs) with chemotherapy for the first-line treatment of patients with (1) unresectable or metastatic esophageal squamous cell carcinoma at different levels of programmed death ligand 1 (PD-L1) protein expression and (2) advanced human epidermal growth factor negative gastric adenocarcinoma, also at different levels of programmed death ligand 1 protein expression. A briefing document for the esophageal cancer discussion says the committee is asked to discuss whether the respective indications for using ICIs in combination with chemotherapy should require patient selection based on PD-L1 expression levels.

The briefing document for the gastric adenocarcinoma indication raises the same issues and questions as the one for the esophageal cancer document.