Posted by Michael Wonder on 30 Oct 2023
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment of untreated, unresectable or metastatic urothelial carcinoma in the European Union.
Bristol Myers Squibb today announced that the EMA has validated its type II variation application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate-901 trial.
