FDA Accepts BMS sBLA for Opdivo-Yervoy in Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has given the green light to Bristol Myers Squibb's (BMS) supplemental biologics license application (sBLA) for a combination therapy involving Opdivo (nivolumab) and Yervoy (ipilimumab). This therapy is designed for use as a first-line treatment in patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The approval covers both adult and adolescent patients aged 12 and older.

This regulatory acceptance comes with a breakthrough therapy designation and priority review status, indicating the potential significance of this treatment. The FDA has set a target date for a decision under the Prescription Drug User Fee Act as June 23, 2025.

The proposal for this new treatment approach is backed by data from the Phase III CheckMate -8HW trial. The study demonstrated that the Opdivo and Yervoy combination achieved progression-free survival when compared to the investigator's choice of chemotherapy in a first-line setting. Additionally, Opdivo as a monotherapy was assessed across all lines of therapy, according to evaluations by a blinded independent central review (BICR). The ongoing trial is also examining other critical outcomes, including overall survival rates.

Dana Walker, the global program lead and vice-president at Bristol Myers Squibb, expressed optimism about this development, noting that it represents an important advance toward delivering an effective dual immunotherapy option for patients with MSI-H or dMMR mCRC. This treatment, she pointed out, could benefit both adults and children facing this challenging medical condition.

Previously, in July 2018, the FDA had approved this combination for use in adults and children aged 12 and above with MSI-H or dMMR mCRC that continued to progress after treatment with oxaliplatin, irinotecan, and fluoropyrimidine. This approval was followed by a similar endorsement from the European Union in December 2024, and more recently by the China National Medical Products Administration, for the first-line treatment of adults with MSI-H or dMMR unresectable or metastatic colorectal cancer.

Opdivo, one of the key components of this dual therapy, functions as a programmed death-1 (PD-1) immune checkpoint inhibitor and is recognized globally, with approvals in over 65 countries. These include major markets such as Japan, the United States, the European Union, and China. In addition to its applications in colorectal cancer, in October 2024, the FDA also approved Opdivo for use in adults with resectable non-small cell lung cancer (NSCLC).

This evolving landscape of immunotherapy highlights the ongoing advancements in cancer treatment, offering promising new options for patients with difficult-to-treat cancers. The acceptance of this combination therapy by the FDA not only marks a significant step forward in colorectal cancer care but also underscores the broader potential of immunotherapy in oncological treatments. As researchers continue to explore the full capabilities of such therapies, patients and healthcare providers alike remain hopeful for improved outcomes and enhanced quality of life for those battling these challenging diseases.