09:15 AM EDT, 04/26/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Friday that a European regulator has recommended approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients having unresectable or metastatic urothelial carcinoma.

The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use is based on data from a phase 3 trial, which showed that an immunotherapy-chemotherapy combination demonstrated a survival benefit compared with standard-of-care chemotherapy alone, the company said.

The recommendation will now be reviewed by the European Commission, which is expected to issue its final decision in June, according to the company.

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