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FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo Plus Yervoy

The application was based on results from the three-arm Phase 3 CheckMate -8HW study.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA granted the application Breakthrough Therapy Designation and Priority Review sta...

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