- Bristol Myers Squibb & Co (NYSE:BMY) has received positive CHMP opinion for Opdivo (nivolumab) plus chemotherapy for first-line treatment of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Opdivo combined with fluoropyrimidine- and platinum-based chemotherapy for esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%.
- The positive opinion is based on the Phase 3 CheckMate -648 trial results.
- The data showed that Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy alone at the pre-specified interim analysis (median, 15.4 months vs. 9.1 months)
- Additionally, the combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and a clinically meaningful increase in objective response rate.
- Price Action: BMY shares traded 2.25% higher at $68.59 on the last check Friday.
