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Friday, February 25, 2022

Why Bristol Myers' Shares Are Trading Higher

 

  • Bristol Myers Squibb & Co  (Get Free Alerts for BMY) has received positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Opdivo combined with fluoropyrimidine- and platinum-based chemotherapy for esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. 
  • The positive opinion is based on the Phase 3 CheckMate -648 trial results.
  • The data showed that Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy alone at the pre-specified interim analysis (median, 15.4 months vs. 9.1 months)
  • Additionally, the combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and a clinically meaningful increase in objective response rate.

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