FDA grants BMS priority review for colorectal cancer combo

Mar 27, 2018

Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration have accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

The FDA granted the application priority review and granted the combination Breakthrough Therapy Designation for this potential indication with an action date of July 10.

“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy 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 BMS's Ian M. Waxman, development lead of gastrointestinal cancers. “We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients.”

This application is based on data from the ongoing Phase 2 CheckMate -142 study evaluating the Opdivo and Yervoy combination in previously treated patients with MSI-H or dMMR mCRC. Data from this study were presented in January at the 2018 Gastrointestinal Cancers Symposium and published simultaneously in the Journal of Clinical Oncology.

Read the press release here