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

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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.

The FDA granted the application priority review and, in February 2018, granted the combination Breakthrough Therapy designation for this potential indication, recognizing the need for new treatment approaches in this patient population. The FDA action date is July 10, 2018.

“The FDA acceptance of this application with Priority Review reinforces our belief in the potential of the nivolumab-plus-ipilimumab combination to treat patients with previously treated metastatic colorectal cancer defined by MSI-H or dMMR biomarkers and is a result of our longstanding commitment to the exploration of I-O/I-O combinations for patient populations with high unmet need,” said Ian M. Waxman, MD, Development Lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We look forward to working with the FDA, with the goal of bringing this combination to these colorectal cancer patients.”

CheckMate-142

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. Data from this study were presented at the 2018 Gastrointestinal Cancers Symposium (Abstract 553) and published simultaneously by Overman et al in the Journal of Clinical Oncology.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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