CHMP recommends nod of Merck Keytruda in combo with trastuzumab, chemotherapy to treat HER2-positive advanced GEJ adenocarcinoma expressing PD-L1
Rahway:Merck, known as MSD outside of the United States and Canada, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, 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).
“This positive CHMP opinion reinforces our commitment to bringing meaningful treatment options to patients living with HER2-positive gastric or GEJ cancer, whose tumors express PD-L1 with a combined positive score ≥1, in the European Union,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to the European Commission’s decision and are excited at the possibility of bringing the first approved immunotherapy regimen for the first-line treatment of these patients with HER2-positive advanced gastric or GEJ cancer to the EU.”
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