Bristol Myers' Immunotherapy Combo Approved for Colorectal and Liver Cancer

Bristol Myers Squibb has received significant approvals for its immunotherapy combination, Opdivo and Yervoy, marking a notable advancement in the treatment landscape for specific cancers. The U.S. Food and Drug Administration (FDA) granted approval for the use of these drugs as a first-line treatment for adult patients suffering from advanced liver cancer, as well as for certain forms of colorectal cancer. These approvals allow the combination therapy to be offered earlier in the treatment process for these patients.

On Friday, the FDA approved the pairing of Opdivo and Yervoy for advanced liver cancer based on findings from the CHECKMATE-9DW clinical trial. This study demonstrated that the combination therapy extended the median survival time by approximately three months in comparison to existing kinase inhibitors, such as sorafenib and Eisai’s Lenvima. Previously, Opdivo and Yervoy were only approved for use in liver cancer patients who had already undergone treatment with sorafenib. In a parallel development, the combination therapy also received approval in Europe earlier in March as a first-line treatment option for advanced liver cancer.

Earlier in the same week, the FDA approved the use of Opdivo and Yervoy for treating advanced colorectal cancer in patients aged 12 and older who exhibit microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics. These features are indicative of DNA repair errors seen in some cancer subtypes. The approval reflects the growing recognition of genetic markers as key considerations in cancer treatment strategies.

Additionally, the FDA converted the accelerated approval of Opdivo, when used alone, into a standard approval for treating this particular form of colorectal cancer. This conversion applies to patients whose disease has progressed despite previous treatment with chemotherapy.

Opdivo and Yervoy function as immune checkpoint inhibitors, a class of drugs that enhance the body’s immune response against cancer cells. Opdivo works by targeting the PD-1 protein, while Yervoy targets CTLA-4, both of which play roles in downregulating immune activity. By inhibiting these proteins, the drugs help to strengthen the body’s natural defenses against cancer.

These approvals signify a promising shift in therapeutic approaches for patients with advanced liver and colorectal cancers, offering new hope for improved outcomes. The ability to use these immunotherapies earlier in the treatment process may potentially lead to better management of these challenging conditions. As the medical community continues to refine and expand treatment options, the impact of these therapies will be closely observed in clinical practice.