Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC.
Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.
First FDA approved in 2014 for advanced melanoma, Opdivo has won a score of oncology indications over the years.
The drug now has five indications covering upper gastroesophageal cancers.
The two recent approvals are based on data from the Phase 3 CheckMate -648 trial, which Bristol Myers Squibb notes is the largest Phase 3 trial of an immunotherapy in first-line ESCC. In that study, Opdivo with chemotherapy offered a superior overall survival rate than chemotherapy alone.
Opdivo with Yervoy also led to improved survivability…