Posted by Michael Wonder on 04 Apr 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated dMMR or MSI-H metastatic colorectal cancer
4 April 2017 - Application based on results from Phase 2 CheckMate-142 study.
Bristol-Myers Squibb Company today announced that the U.S. FDA accepted a supplemental biologics License application that seeks to extend the use of Opdivo (nivolumab) 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 FDA granted the application priority review, and the FDA action date is 2 August 2017.
