FDA Approves Bristol-Myers Squibb's Opdivo-Yervoy Combo for Colorectal Cancer

Bristol-Myers Squibb (BMY.US) announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

This approval is based on the results of the Phase 3 clinical trial CheckMate-8HW, which were released at the end of January. The trial evaluated the combination of Opdivo and Yervoy compared to investigator's choice of chemotherapy (mFOLFOX-6 or FOLFIRI regimens, with or without bevacizumab or cetuximab) in patients with MSI-H or dMMR mCRC. The median follow-up period for the trial was 47 months. The results showed that patients treated with Opdivo and Yervoy had a 38% reduction in the risk of disease progression or death compared to those treated with Opdivo alone. Previously, the CheckMate-8HW trial results indicated that the combination therapy reduced the risk of disease progression or death by 79% compared to investigator's choice of chemotherapy.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses, utilizing the body's own immune system to combat cancer. Yervoy targets and inhibits CTLA-4, an antibody that enhances T-cell activity to increase tumor-killing capability. Yervoy was approved by the FDA in 2011 for the treatment of late-stage melanoma and was the first CTLA-4 antibody drug to receive global market approval.

This approval represents a significant advancement in the treatment of MSI-H or dMMR mCRC, offering a new therapeutic approach that leverages the immune system to fight cancer. The combination of Opdivo and Yervoy has demonstrated promising results in enhancing the body's natural defenses against cancer cells, providing hope for improved survival rates and quality of life for patients. This development highlights Bristol-Myers Squibb's commitment to innovation in oncology and its dedication to bringing forward new treatments that address unmet medical needs. The approval is expected to positively impact the colorectal cancer treatment landscape, offering patients and healthcare providers a new, effective option for managing this challenging disease.