Posted by Michael Wonder on 25 May 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 trial.
Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of Keytruda in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 (Combined Positive Score ≥10).
