The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The FDA’s decision was based on the review of a late-stage trial that successfully met its primary endpoints of overall survival (OS) and progression-free survival (PFS).
Clinical data revealed that the addition of Opdivo to the cisplatin and gemcitabine regimen resulted in an increase in median OS from 18.9 to 21.7 months, which corresponds to a 22% reduction in the risk of death. Median PFS also improved from 7.6 to 7.9 months, indicating a 28% reduction in the risk of disease progression or death.
Opdivo had previously received approval in the US as an adjuvant treatment for UC and for the treatment of locally advanced or metastatic UC.- Flcube.com
