FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Previously Treated MSI-H or dMMR Metastatic Colorectal Cancer

On March 27, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults 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 application is based on data from the ongoing phase II CheckMate-142 study evaluating the nivolumab-plus-ipilimumab combination in previously treated patients with MSI-H or dMMR metastatic colorectal cancer. Tasman Health Care have been involved in the CA209-142 study for over three years; for further information please click here.