Opdivo Accelerated Approval for Colorectal Cancer

FDA has granted Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on data from the CHECKMATE 142 study, a multicenter, single arm study conducted in 53 patients with locally determined dMMR or MSI-H metastatic colorectal cancer who had disease progression during, after, or were intolerant to prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The objective response rate as assessed by independent radiographic review was 28% (n=15) in the 53 patients who received prior fluoropyrimidine, oxaliplatin, and irinotecan, an agency release says. Responses lasted six or more months for 67% of patients. Additionally, There was one complete response and 14 partial responses.