The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT). With the approval based on the Phase 3 CheckMate -577 trial which indicated using Opdivo in combination with neoadjuvant CRT and complete surgical resection increased the chance of primary endpoint of disease-free survival (DFS) in patients by two-fold, the treatment can now be used in all 27 member states of the European Union (EU), and in Iceland, Liechtenstein, and Norway as well. In addition to the EC’s approval, Opdivo received U.S. Food and Drug Administration (FDA) approval in May 2021 for the treatment of completely resected esophageal or GEJ cancer in patients with residual pathologic disease who have already undertaken CRT.
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