The Cancer Letter

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Drugs & Targets

Opdivo receives EC approval in Esophageal/GEJ indication

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The European Commission has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. 

Opdivo is sponsored by Bristol Myers Squibb. 

Approval is based on phase III results from the CheckMate -577 trial. Opdivo is now the first and only approved adjuvant therapeutic option in the European Union.

Opdivo also received approval from FDA in May 2021 for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received CRT.

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