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New indication alert: Second Positive CHMP opinion for Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction

Oct 13, 2023

Merck announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

This will be the second indication for Keytruda® for the first-line treatment of such cancers in EU, following approval of Keytruda® in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy in August 2023.