EMA Will Review BMS’ Esophageal and GEJ Cancer Drug

The European Medicines Agency (EMA) has accepted Bristol Myers Squibb’s (BMS) marketing authorization application for Opdivo (nivolumab) as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer.

BMS is seeking EU approval for its blockbuster cancer drug for treating esophageal or GEJ cancer in adults with residual pathologic disease after neoadjuvant chemoradiotherapy and resection.

The application is based on phase 3 trial results that showed the drug was safe and effective and it doubled median disease-free survival, its primary endpoint, in adult patients with esophageal or GEJ cancer after neoadjuvant chemoradiotherapy and tumor resection.