KEYTRUDA® (Pembrolizumab)

The FDA on November 7, 2023, revised the existing indication of KEYTRUDA® (Pembrolizumab) with Trastuzumab, Fluoropyrimidine, and Platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test. KEYTRUDA® is a product of MERCK & Co., Inc.