Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The FDA granted the application priority review and, in February 2018, granted the combination Breakthrough Therapy Designation for this potential indication, recognizing the need for new treatment approaches in this patient population. The FDA action date is July 10, 2018.
“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated metastatic colorectal cancer defined by MSI-H or dMMR biomarkers, and is a result of our longstanding commitment to the exploration of I-O/I-O combinations for patient populations with high unmet need,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients.”
This application is based on data from the ongoing Phase 2 CheckMate -142 study evaluating the Opdivo and Yervoy combination in previously treated patients with MSI-H or dMMR mCRC. Data from this study were presented in January at the 2018 Gastrointestinal Cancers Symposium and published simultaneously in the Journal of Clinical Oncology.
The FDA’s Breakthrough Therapy Designation is a process intended to enable timely patient access by expediting the development and review of medicines for serious conditions where preliminary clinical evidence indicates a substantial improvement over available therapies on one or more clinically significant endpoints.
Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. In the U.S., CRC is the third most common cancer with more than 140,000 new cases expected to be diagnosed annually, and the third leading cause of cancer-related deaths among men and women combined.
DNA mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 15% of CRC patients and 4-5% of metastatic CRC patients have MSI-H or dMMR biomarkers. Patients with MSI-H or dMMR metastatic CRC are less likely to benefit from conventional chemotherapy and typically have a poor prognosis. Routine testing to confirm MSI-H or dMMR status should be conducted for all CRC patients.