29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an immunotherapy-chemotherapy combination to demonstrate survival benefit versus standard of care chemotherapy alone.
Bristol Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.