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MARCH 8, 2024

FDA Approves Opdivo Combination for Unresectable or Metastatic Urothelial Carcinoma


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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