Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients aged ≥12 years with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 

In the Phase 2, multicenter, open-label, single-arm CheckMate -142 trial (n=74), qualified patients received Opdivo 3mg/kg intravenously (IV) every 2 weeks. The outcome measures included independent radiographic review committee-assessed confirmed overall response rate (ORR) and duration of response. 

The data showed 28% of patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan responded to Opdivo. Of these, complete response was seen in 1.9% and partial response was seen in 26%. The median duration of response was not reached among the responders (range 2.8–22.1 months). Overall, 32% of all study patients responded to Opdivo with complete response seen in 2.7% and partial response in 30%.

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The FDA’s accelerated approval was based on ORR and duration of response. Continued approval may depend on verification and description of clinical benefit in confirmatory trials. 

Opdivo, a programmed death receptor-1 (PD-1) blocking antibody, is already indicated for the treatment of various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, and urothelial carcinoma. It is available as 40mg/4mL and 100mg/10mL strength solutions in single-dose vials.

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