On July 31, 2017, the FDA approved a new use for Opdivo (nivolumab; from Bristol-Myers Squibb) for adults with mismatch repair–deficient (dMMR) and microsatellite instability–high (MSI-H) metastatic colorectal cancer that progressed after treatment with a chemotherapy regimen.
The approval of this new indication was based on a clinical trial showing that 28% of adult patients responded to treatment with Opdivo, including 1 complete response (no sign of disease) and 14 partial responses. In 67% of patients, the responses lasted 6 months or longer. Among the 74 patients in the overall population, there was an objective response rate of 32%.
Opdivo was previously approved by the FDA for many types of cancer, including melanoma, lung cancer, kidney cancer, head and neck cancer, liver cancer, lymphoma, and bladder cancer.
