Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review for the supplemental Biologics License Application (sBLA) of Opdivo (nivolumab) to extend its use to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

The sBLA submission was supported by data from the Phase 2 CheckMate-142 trial that evaluated Opdivo in patients with dMMR or MSI-H metastatic colorectal cancer. The efficacy endpoints included objective response rate (ORR) based on the Response Evaluation criteria in Solid Tumors (RECIST) version 1.1, duration of response, progression-free survival (PFS) and overall survival. 

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Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for various renal and urologic cancers, head and neck cancer, lymphoma, skin cancer, and lung cancer.  

Opdivo is available as 10mg/mL strength in 4mL and 10mL single-use vials.

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