07:40 AM EDT, 05/29/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Wednesday that the European Commission has approved its cancer drug Opdivo, or nivolumab, combined with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic urothelial carcinoma in adults.

The company said the approval was based on phase 3 trial results showing "statistically significant and clinically meaningful improvements" in overall survival and progression-free survival of patients who received Opdivo combined with cisplatin and gemcitabine followed by Opdivo monotherapy, according to Bristol-Myers.

The Opdivo combination therapy is the first concurrent immunotherapy-chemotherapy approved for unresectable or metastatic urothelial cancer in all 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway, Bristol-Myers said.

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