Bristol Myers Squibb's Opdivo and Yervoy Accepted by FDA for Colorectal Cancer Treatment
Tuesday, February 25, 2025
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics licence application (sBLA) for Opdivo (nivolumab) and Yervoy (ipilimumab) as a potential first-line treatment for adult and paediatric patients aged 12 and above with mismatch repair deficient (dMMR) colorectal cancer (mCRC).
Colorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide and a leading cause of cancer-related deaths. In 2020, approximately 1,931,000 new cases were reported.
Opdivo is a PD-1 immune checkpoint inhibitor designed to restore anti-tumour immune response. It has been approved in over 65 countries, including the US, EU, Japan, and China.
The combination of Opdivo and Yervoy was the first immunotherapy regimen approved for metastatic melanoma and is currently authorised in more than 50 countries.
Yervoy is a monoclonal antibody targeting CTLA-4, a protein that regulates T-cell activity. Blocking CTLA-4 enhances immune response against tumours.
The CheckMate -8HW trial is a Phase 3 randomised, open-label study comparing Opdivo plus Yervoy against Opdivo monotherapy or investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with MSI-H or dMMR unresectable or metastatic colorectal cancer.
The application is supported by data from the Phase 3 CheckMate -8HW study, which demonstrated that the combination therapy met the dual primary endpoints of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in the first-line setting and compared to Opdivo monotherapy across all lines of therapy.
The findings were evaluated by a Blinded Independent Central Review (BICR).
Opdivo and Yervoy were previously approved by the FDA in July 2018 for treating MSI-H or dMMR mCRC that had progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
In December 2024, the European Union approved the combination for first-line treatment of MSI-H or dMMR unresectable or metastatic colorectal cancer, followed by approval in China in October 2024 for the same indication.
Source: bms.com
