The Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) to serve as a possible first-line treatment for adult and pediatric patients 12 years old and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC), according to a news release from the drugs’ manufacturer, Bristol Myers Squibb.
The agency, according to the news release, has granted the application Breakthrough Therapy Designation and Priority Review status, and has assigned a Prescription Drug User Fee Act target action date of June 23.
“Today’s milestone brings us one step closer to providing an effective dual immunotherapy treatment option to adult and pediatric patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer,” said Dr. Dana Walker, vice president, Opdivo global program lead, Bristol Myers Squibb. “We look forward to potentially bringing a new standard of care treatment option to this patient population.”
The application, according to the news release, is based on the results of the phase 3 CheckMate-8HW study, in which the treatment combination reportedly met the study’s dual primary endpoints of progression-free survival compared to investigator’s choice of chemotherapy in the first-line setting and compared to standalone Opdivo across all lines of therapy.
Glossary:
Unresectable: cannot be removed by surgery.
Metastatic: cancer that has spread from its original location.
Breakthrough Therapy designation: according to the FDA, breakthrough therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy.
Priority Review status: according to the FDA, Priority Review status directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.
Prescription Drug User Fee Act target action date: the deadline for the FDA to review and potentially approve a product.
Progression-free survival: the time a patient lives without their disease spreading or worsening.
In January 2024, Bristol Myers Squibb announced results from the trial showing that the dual immunotherapy combination resulted in a 79% reduction in the risk of disease progression or death when compared with investigator’s choice of chemotherapy, followed by the announcement in January 2025 that patients treated with the combination experienced a 38% reduction in the risk of disease progression or death when compared with Opdivo monotherapy.
The combination was approved by the FDA in July 2018 for the treatment of patients ages 12 years old and older with MSI-H or dMMR mCRC that had progressed after receiving treatment with fluoropyrimidine, oxaliplatin and irinotecan.
Opdivo, a type of immunotherapy known as an immune checkpoint inhibitor, binds to the protein PD-L1 on the surface of some cancer cells to prevent cancer cells from suppressing the immune system, according to the National Cancer Institute. Yervoy, the National Cancer Institute stated, is a monoclonal antibody and immune checkpoint inhibitor that binds to the protein CTLA-4 in order to help immune cells better kill cancer cells.
dMMR CRC, according to Bristol Myers Squibb, happens when the proteins that repair mismatch errors in DNA replication are missing or non-functional, which results in MSI-H tumors, and approximately 5% to 7% of patients with mCRC have dMMR or MSI-H tumors.
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