The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive breakthrough therapy designation (BTD).
Yervoy, the pioneering anti-CTLA-4 monoclonal antibody (mAb), was granted marketing approval in the US in 2011 and in China in 2021. Opdivo, the inaugural PD-1 inhibitor globally, received its initial market approval in China in 2018.
The Yervoy and Opdivo combination therapy stands as the world’s first immuno-oncology combination to gain regulatory approval, with the initial award granted in October 2015. This pairing has garnered regulatory nods for six indications across over 50 markets, encompassing lung cancer, pleural mesothelioma, melanoma, renal cancer, colorectal cancer, and liver cancer. The regimen received its initial approval in China for the treatment of inoperable, treatment-naïve non-epithelioid malignant pleural mesothelioma in June 2021. Data from a Phase III clinical study in non-epithelioid malignant pleural mesothelioma presented in January 2024 demonstrated that the combination reduced the risk of disease progression or death by 79% compared to nivolumab monotherapy or chemotherapy.- Flcube.com
