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