The U.S. Food and Drug Administration granted priority review to Bristol-Myers Squibb Co.'s supplemental biologics license application to market the Opdivo and Yervoy combination for colorectal cancer.
Bristol is seeking approval for the combination's use in treating adults with microsatellite instability-high or DNA mismatch repair deficient colorectal cancer that has spread and progressed after receiving prior chemotherapy treatments.
The action date for the application is July 10.
The combination received the FDA's breakthrough therapy designation in February to expedite development.
Bristol's supplemental application is backed by the results of the ongoing phase 2 CheckMate-142 trial studying the combination in previously treated patients.