FDA provides accelerated approval for Yervoy + Opdivo combination to treat microsatellite instability high or mismatch repair deficient metastatic colorectal cancer.

Bristol-Myers Squibb Company announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the FDA for the treatment of adult and pediatric patients 12 years and older 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. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This approved indication was based on data from the ongoing Phase II CheckMate -142 study evaluating the Opdivo + Yervoy combination in patients with MSI-H or dMMR mCRC previously treated with a fluoropyrimidine-, oxaliplatin- or irinotecan-based chemotherapy. The application was granted Priority Review and Breakthrough Therapy Designation by the FDA.

Comment: The approval covers microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. About 4% to 5% of metastatic colorectal cancer patients have those biomarkers, and they are less likely to benefit from conventional chemotherapy..