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Revised Indication Alert: FDA Amends Keytruda® (Pembrolizumab) Gastric Cancer Indication

Nov 7, 2023

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy.  The updated indication is restricted to patients whose tumors express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.  Both the original and updated indication were approved under accelerated approval regulations.

The same indication was approved in Europe in August 2023, similarly limited to adults whose tumors express PD-L1 ( [CPS]≥1).