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According to foreign media reports, Merck announced on May 24 that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of Merck’s anti-PD-1 therapeutic drug KEYTRUDA combined with platinum and fluorouracil.
CHMP’s positive opinion is based on the results of the key Phase 3 KEYNOTE-590 trial.
In this trial, KEYTRUDA combined 5-fluorouracil (5-FU) and cisplatin, compared with placebo combined 5-FU and cisplatin, regardless of histology or PD-L1 expression, overall survival and progression-free survival Significant improvement during the period.
Reference source: Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as First-Line Treatment for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma