The U.S. Food and Drug Administration (FDA) on Tuesday approved Bristol Myers Squibb ( BMY ) & Co’s 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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Opdivo plus Yervoy met the dual primary endpoints of progression-free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and compared to chemotherapy in the first-line setting.

In the CheckMate-8HW trial, Opdivo plus Yervoy demonstrated a 38% reduction in the risk of disease progression or death vs. Opdivo monotherapy in immunotherapy-naïve patients across all lines of therapy.

Assessing the dual primary endpoint of PFS, the trial demonstrated that median PFS was not reached with Opdivo plus Yervoy and was 39.3 months with Opdivo monotherapy.

PFS rates at 12, 24, and 36 months were also numerically higher than Opdivo monotherapy (76% vs. 63%, 71% vs. 56%, and 68% vs. 51%, respectively).

Opdivo plus Yervoy also met a key secondary endpoint, demonstrating a superior overall response rate (ORR) compared to Opdivo monotherapy (n=296, 71% vs. n=286, 58%)

The Opdivo plus Yervoy vs. chemotherapy arm of the CheckMate-8HW trial showed that the combination regimen reduced the risk of cancer progression or death by 79% compared to chemotherapy in first-line patients.

This arm also assessed the other dual primary endpoint of PFS, where median PFS was not reached with Opdivo plus Yervoy compared to 5.8 months with chemotherapy.

PFS rates were numerically higher with Opdivo plus Yervoy vs. chemotherapy at 12- and 24-months (79% vs. 21% and 72% vs. 14%, respectively).

Opdivo as a single agent, or in combination with Yervoy, was previously granted accelerated approval in MSI-H/dMMR CRC adult and pediatric patients (12 years and older) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

The FDA decision converts this second-line indication to full approval for Opdivo monotherapy. It expands the indication for Opdivo plus Yervoy into the first-line setting based on the CheckMate-8HW trial.

Price Action: BMY stock is down 5.31% at $50.25 at the last check on Wednesday.

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