CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 13, 2018—The FDA granted accelerated approval to ipilimumab (Yervoy, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo, BMS) for the treatment of patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Approvals were based on data from the ongoing phase two CheckMate 142 study; the Opdivo plus Yervoy cohort of the trial enrolled MSI-H/dMMR mCRC patients who had received at least one prior line of therapy for metastatic disease, and efficacy was analyzed for patients who had received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan (82 of the total 119 patients) and also for all enrolled patients.