7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Efficacy was evaluated in CHECKMATE-901, a randomised, open-label trial enrolling 608 patients with previously untreated unresectable or metastatic urothelial carcinoma.