The Food and Drug Administration announced it has approved nivolumab, or Opdivo, marketed by Bristol Myers (BMY) Squibb, with ipilimumab, or Yervoy, marketed by Bristol Myers, for adult and pediatric patients 12 years of age and older 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 adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
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