Expanded Gastric Cancer Indication for Keytruda Under FDA Review
The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application for pembrolizumab (Keytruda®) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Findings showed the pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in overall survival (primary endpoint) compared with chemotherapy alone, regardless of PD-L1 expression.
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