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www.fdanews.com/articles/203765-bms-opdivo-wins-eu-approval-for-esophageal-or-gastroesophageal-junction-cancer
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BMS’ Opdivo Wins EU Approval for Esophageal or Gastroesophageal Junction Cancer

August 2, 2021

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has secured European Commission approval as an adjuvant treatment for adults with esophageal or gastroesophageal junction (GEJ) cancer who still have the disease following neoadjuvant chemoradiotherapy.

The approval was supported by a 794-participant phase 3 study in which Opdivo given after neoadjuvant chemoradiotherapy and surgical removal doubled disease-free survival vs. placebo.

The drug belongs to an immunotherapy class known as checkpoint inhibitors, which block certain proteins that can reduce immune responses and stop T-cells from killing cancer cells.  

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