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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. ....

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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. ....

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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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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. ....

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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 ....

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