Bristol Myers Squibb wins rapid FDA nod for colorectal cancer combo

USA – The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s immunotherapy duo, Opdivo (nivolumab) and Yervoy (ipilimumab).

The combination is approved as a first-line treatment for patients with a specific subtype of colorectal cancer (CRC).

The approval targets previously untreated, metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) CRC in patients aged 12 and older whose cancer is not amenable to surgery.

This FDA decision also converts a prior 2018 accelerated approval for the Opdivo/Yervoy combo as a second-line therapy into a full approval, marking a major milestone in the treatment of aggressive colorectal cancer.

Notably, this approval came weeks ahead of the FDA’s expected action date of June 23, highlighting the urgency and clinical significance of the new treatment.

The combination had already secured approvals in the European Union and China late last year for the same indication.

Data from the phase 3 CheckMate-8HW trial showed that the Opdivo/Yervoy combo reduced the risk of disease progression or death by 38% compared to Opdivo plus investigator’s choice of chemotherapy.

After nearly four years of follow-up, more than 50% of patients on the combo therapy were progression-free, with a median progression-free survival (PFS) of just over 39 months.

This positions Opdivo/Yervoy as a strong immunotherapy-based alternative to Merck’s Keytruda (pembrolizumab), which has been the U.S. standard of care since 2020 for MSI-H/dMMR CRC.

Keytruda had demonstrated a 40% reduction in progression risk at two years and a 34% PFS rate at the five-year mark in the KEYNOTE-177 trial.

While the efficacy of the BMS combo appears promising, oncologists will need to weigh potential side effects.

In the CheckMate-8HW study, treatment-related adverse events were higher for the Opdivo/Yervoy group compared to Opdivo alone, with a treatment discontinuation rate of 9% versus 4%.

Dr. Heinz-Josef Lenz of USC Norris Comprehensive Cancer Center noted the potential for this regimen to “redefine traditional approaches to care.”

Nicole Sheahan, president of the Global Colon Cancer Association, added that despite CRC’s prevalence, “there remains a high unmet need,” especially as incidence rises in those under 50.