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KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
KEYTRUDA
Date registered
Evaluation commenced
Decision date
Approval time
204 (255 working days)
Active ingredients
pembrolizumab
Registration type
EOI
Indication
Gastric Cancer
KEYTRUDA® (pembrolizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GOJ) adenocarcinoma that is not HER2-positive.
KEYTRUDA® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GOJ) adenocarcinoma, whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.