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Tuesday, April 8, 2025

Bristol Opdivo plus Yervoy FDA OK for colorectal cancer

 Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date

https://www.biospace.com/press-releases/u-s-food-and-drug-administration-approves-opdivo-nivolumab-plus-yervoy-ipilimumab-as-a-treatment-for-patients-with-previously-untreated-microsatellite-instability-high-or-mismatch-repair-deficient-unresectable-or-metastatic-colorectal-cancer1

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