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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence

Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial First opinion to be granted for an anti-PD-1/L1 therapy in resectable non-small.

United statesStatement of merck co incEuropean commissionEuropean unionAmerican joint committee on cancerMerck research laboratoriesExchange commissionMerck co incEuropean medicines agencyMedicinal productsHuman useAmerican joint committeeMarjorie greenMerck researchSelected important safetyImportant safety information

FDA Approves Merck s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma -November 16, 2023 at 05:41 pm EST

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone Approval marks seventh.

United statesStatement of merck co incDrug administrationExchange commissionPatient support programMerck access programMerck patient support programMerck co incSelected important safetyImportant safety informationFatal immune mediated adverseWhich can present with diabeticNervous systemConnective tissuePatients with multipleNeck squamous cell

Merck & Co , Inc : Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS =1)

Merck & Co , Inc : Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS =1)
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United statesMichael mcardlePeter dannenbaumDamini chokshiJulie cunninghamMerck research laboratoriesEuropean commissionExchange commissionStatement of merck co incEuropean unionMerck co incEuropean medicines agencyMedicinal productsHuman useCombined positive scoreMarjorie green

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1) -October 13, 2023 at 07:46 am EDT

Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial If approved, a KEYTRUDA combination would become an option in the EU for the treatment of both.

United statesMerck co incEuropean unionStatement of merck co incExchange commissionMerck research laboratoriesEuropean commissionEuropean medicines agencyMedicinal productsHuman useCombined positive scoreMarjorie greenMerck researchSelected important safetyImportant safety informationFatal immune mediated adverse

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

RAHWAY, N.J. (BUSINESS WIRE) Oct 13, 2023

United statesPeter dannenbaumJulie cunninghamDamini chokshiMichael mcardleEuropean commissionMerck co incStatement of merck co incEuropean unionMerck research laboratoriesExchange commissionEuropean medicines agencyMedicinal productsHuman useCombined positive scoreMarjorie green