Posted by Michael Wonder on 01 Aug 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
1 August 2017 - Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% (95% CI: 17-42; 15/53) among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Bristol-Myers Squibb Company today announced the U.S. FDA has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and paediatric (12 years and older) patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
