Bristol Myers Gets Positive CHMP Opinion For Opdivo To Treat Esophageal Cancer

(RTTNews) - Bristol Myers Squibb (BMY) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended approval of Opdivo or nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction or GEJ cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy or CRT.

The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.

The positive opinion was based on results from the Phase 3 CheckMate -577 trial which showed that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies.

Opdivo is approved in the United States for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received neoadjuvant CRT.