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

Jul 21, 2023

Merck announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the 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 (Combined Positive Score [CPS] ≥1).

If approved, Keytruda® would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU.