The FDA has approved Bristol-Myers Squibb Company's (BMY.US) Opdivo+Yervoy combination treatment for colorectal cancer in collaboration with United Therapeutics Corporation.

Bristol-Myers Squibb Company (BMY.US) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has approved its blockbuster PD-1 inhibitor Opdivo (nivolumab) in combination with the CTLA-4 targeted antibody Yervoy (ipilimumab) for the treatment of metastatic colorectal cancer (mCRC) in adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) phenotypes. In late January, Bristol-Myers Squibb Company released the analysis results of the Phase 3 clinical trial CheckMate-8HW. The study evaluated Opdivo in combination with Yervoy compared to investigator's choice of chemotherapy (mFOLFOX-6 or FOLFIRI regimens, with or without bevacizumab or cetuximab) for the treatment of patients with MSI-H or dMMR phenotype mCRC. The analysis showed that at a median follow-up of 47 months, patients treated with Opdivo in combination with Yervoy had a 38% reduction in the risk of disease progression or death across all lines of therapy, compared to Opdivo monotherapy. Previously, the results of the CheckMate-8HW trial showed that Opdivo in combination with Yervoy 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 response and utilize the body's own immune system to fight cancer. Yervoy targets and inhibits CTLA-4, enhancing T cell activity to increase tumor-killing capabilities. The product was FDA approved in 2011 for the treatment of advanced melanoma, making it the first CTLA-4 antibody drug to be approved and marketed globally.