Europe - EC Decision granted for BMS' Opdivo combo extension of indication in unresectable or mUC

BMS has announced that the European Commission has granted its Decision to Opdivo (nivolumab) for its extension of indication in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

This Decision is based on results from the CheckMate-901 trial studying Opdivo in combination with cisplatin and gemcitabine. In CheckMate-901, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone, as assessed by Blinded Independent Central Review (BICR).

Reference link: BMS press release