Bristol-Myers Squibb (BMY) said Monday the US Food and Drug Administration has accepted its supplemental biologics license application for colorectal drug Opdivo plus Yervoy as a potential first-line treatment option for adult and pediatric patients.
The application is for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
The FDA granted the application a priority review status with a goal date of June 23, under the Prescription Drug User Fee Act.
The application was based on results from the three-arm phase 3 CheckMate -8HW study demonstrating that Opdivo plus Yervoy met the dual primary endpoints of progression-free survival, the company said.
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