Bristol Myers Squibb announces that it has received approval from the European Commission (EC) for Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

This decision is based on the results of the phase III CheckMate -901 trial, which demonstrated statistically and clinically significant improvements in overall survival and progression-free survival compared with chemotherapy alone.

This approval of Opdivo in combination for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma is valid in the 27 EU member states, as well as in Iceland, Liechtenstein and Norway.

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