Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that MSI-H status confers therapeutic sensitivity to Nivolumab in patients with Colorectal Adenocarcinoma.
The U.S. Food and Drug Administration (FDA) granted approval to nivolumab as a single agent for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This statement is based on a regulatory approval from the Food and Drug Administration:
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.