Merck's Keytruda/Chemo Combo Therapy Wins EU Backing For Esophageal Cancer

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval for Merck & Co Inc's MRK Keytruda (pembrolizumab) combined with chemotherapy for esophageal cancer.
The recommendation is for the first-line treatment in patients with locally advanced unresectable or metastatic carcinoma of the esophagus, or human epidermal growth factor receptor 2-negative gastroesophageal junction adenocarcinoma in adults, whose tumors express PD-L1.
A final decision is expected in the second quarter of 2021.
The positive CHMP opinion is based on results from the Phase 3 KEYNOTE-590 trial, in which Keytruda plus 5-fluorouracil and cisplatin reduced the risk of death by 27% and disease progression or death by 35%, 5-FU and cisplatin alone.
Price Action: MRK shares are up 0.10% at $79.23 during the market session on the last check Monday.