FDA Approves Opdivo Combination for Unresectable or Metastatic Urothelial Carcinoma

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 (UC).

Efficacy was evaluated in CheckMate-901, a randomized, open-label trial enrolling 608 patients with previously untreated unresectable or metastatic UC. Patients were randomized (1:1) to receive either nivolumab in combination with cisplatin and gemcitabine (up to six cycles) followed by