Posted by Michael Wonder on 27 Mar 2018
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for previously treated patients with MSI-H or dMMR metastatic colorectal cancer for priority review
27 March 2018 - The FDA also granted the Opdivo plus Yervoy combination breakthrough therapy designation for this potential indication.
Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license application 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, in February 2018, granted the combination breakthrough therapy designation for this potential indication, recognising the need for new treatment approaches in this patient population. The FDA action date is 10 July 2018.
