Bristol Myers (BMY) Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a potential first-line treatment option for adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act goal date of June 23, 2025.
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