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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.
Chemotherapy, as the first-line treatment for adult patients with unresectable or metastatic esophageal cancer, or human epidermal growth factor receptor 2 (HER2) negative gastroesophageal junction (GEJ) adenocarcinoma.
The CHMP proposal will now be reviewed by the European Commission to obtain EU marketing authorization, and the final decision is expected to be made in the second quarter of 2021.
CHMP’s positive opinion is based on the results of the key Phase 3 KEYNOTE-590 trial.
KEYNOTE-590 is a global multicenter, randomized, double-blind, controlled Phase III clinical study.
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.
KEYTRUDA combined with 5-FU and cisplatin reduced the risk of death by 27% (HR=0.
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
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.
Chemotherapy, as the first-line treatment for adult patients with unresectable or metastatic esophageal cancer, or human epidermal growth factor receptor 2 (HER2) negative gastroesophageal junction (GEJ) adenocarcinoma.
CHMP’s positive opinion is based on the results of the key Phase 3 KEYNOTE-590 trial.
KEYNOTE-590 is a global multicenter, randomized, double-blind, controlled Phase III clinical study.
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.
KEYTRUDA combined with 5-FU and cisplatin reduced the risk of death by 27% (HR=0.
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
