FDA Approves Bristol Myers' Opdivo Plus Yervoy Combo For Untreated Colorectal Cancer Patients

The U.S. Food and Drug Administration (FDA) on Tuesday approved Bristol Myers Squibb & Co’s (NYSE:BMY) Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

The approval comes ahead of over two months of the June 23, 2025, Prescription Drug User Fee Act goal date.

The approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus Yervoy (n=202) vs. investigator’s choice chemotherapy (n=101) (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in the first-line setting.

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https://www.benzinga.com/25/04/44715789/fda-approves-bristol-myers-opdivo-plus-yervoy-combo-for-untreated-colorectal-cancer-patients