Posted by Michael Wonder on 03 Feb 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
2 February 2017 - Approval based on CheckMate-275, in which Opdivo demonstrated an objective response rate of 19.6% (95% CI: 15.1-24.9; 53/270 patients).
Bristol-Myers Squibb Company today announced the U.S. FDA has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neo-adjuvant or adjuvant treatment with platinum-containing chemotherapy.
This indication is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
