Bristol-Myers Squibb (BMY) received approval from the US Food and Drug Administration for nivolumab with ipilimumab to treat a colorectal cancer type in patients 12 years or older, the regulator said Tuesday.
The combination was tested in a randomized, three-arm, open-label trial in immunotherapy-naive patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
The FDA also converted the accelerated approval to regular approval for single agent nivolumab for patients 12 years or older with the disease, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
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