Bristol Myers Squibb today announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo (nivolumab) as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. Validation of the application confirms that submission is complete, and the EMA’s centralized review process will begin.

The application is based on results from the Phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival (DFS) - its primary endpoint – in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous Opdivo studies.

“The majority of esophageal cancer patients with localized disease who are treated with both chemotherapy and surgery do not achieve complete response. Their risk of recurrence is unacceptably high and the establishment of more effective treatment options is essential,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “The EMA’s decision to validate our application represents important progress for the esophageal cancer community, and we look forward to potentially bringing Opdivo to patients in the EU who may benefit.”

Bristol Myers Squibb thanks the patients and investigators who have been involved in the CheckMate -577 trial.