FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1

Abstract

This report presents evidence for FDA approval of pembrolizumab for the treatment of adult and pediatric patients with either unresectable or metastatic, microsatellite instability‐high (MSI‐H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment, and who have no satisfactory alternative treatment options, or who have metastatic, MSI‐H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.