Merck Receives Full FDA Approval for Keytruda Plus Trastuzumab in HER2+ Gastric Cancer

Merck today announced that the FDA has converted the accelerated approval of KEYTRUDA (pembrolizumab) plus trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy to full approval for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. The conversion was based on overall survival data from the Phase 3 KEYNOTE-811 trial, which demonstrated a statistically significant improvement in OS. This full approval reinforces KEYTRUDA plus trastuzumab plus chemotherapy as a standard of care in HER2+ gastric cancer.