Bristol Myers Colorectal Cancer Treatment Goes Under Priority FDA Review
1. FDA accepted sBLA for Opdivo plus Yervoy in MSI-H/dMMR mCRC. It targets first-line treatment. 2. FDA granted Breakthrough Therapy Designation and Priority Review with a PDUFA goal of June 2025. It enhances confidence in the application. 3. Phase 3 CheckMate -8HW met dual primary endpoints compared to chemotherapy and monotherapy. This success bolsters clinical validation. 4. Previously approved indications include pediatric and adult patients; similar positive trends seen in NSCLC study. BMY stock is up 2.97%.