Posted by Michael Wonder on 09 Nov 2023
FDA amends pembrolizumab’s gastric cancer indication
9 November 2023 - On 7 November 2023, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastro-oesophageal junction adenocarcinoma.
This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumours express PD-L1 (CPS ≥ 1) as determined by an FDA approved test.
