The European Medicines Agency (EMA) has launched its centralized review process for Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for oesophageal or gastroesophageal junction (GEJ) cancer.
BMS is eyeing EU approval for the checkpoint inhibitor in adult patients with residual pathological disease following neoadjuvant chemoradiotherapy (CRT) and resection.
The marketing authorisation application for Opdivo in this setting is based on results from the phase III CheckMate-577 trial.
In this study, Opdivo doubled the median disease-free survival rate in patients with oesophageal cancer, following neoadjuvant CRT and tumour resection – the primary endpoint of the trial.
Follow up for the overall survival rate – the secondary endpoint – is still ongoing, BMS added in a statement.
The safety profile for the PD-L1 inhibitor as an adjuvant therapy in the CheckMate-577 trial was also consistent with previously reported Opdivo studies.
“The majority of oesophageal cancer patients with localised 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, development lead, gastrointestinal cancers, Bristol Myers Squibb.
“The EMA’s decision to validate our application represents important progress for the oesophageal cancer community, and we look forward to potentially bringing Opdivo to patients in the EU who may benefit,” he added.
