The US Food and Drug Administration (FDA) granted accelerated approval to nivolumab for patients aged 12 and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) who fail fluoropyrimidine, oxaliplatin, and irinotecan therapy.1
The FDA granted approval based on evidence from CheckMate-142 trial (ClinicalTrials.gov Identifier: NCT02060188). Study researchers administered intravenous nivolumab 3 mg/kg every 2 weeks to 74 patients with MSI-H or dMMR mCRC who progressed after fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy.
Nivolumab demonstrated an overall response rate (ORR) of 32% (95% CI, 17%-42%) in all patients, including 2 patients who exhibited a complete response (CR) and 22 patients who had partial responses (PR). The median duration of response was not reached in these patients.
Accelerated approval was granted based on the ORR and duration of response observed in clinical trials.
The most frequently reported adverse events (AEs) were nausea, diarrhea, constipation, decreased appetite, back pain, arthralgia, musculoskeletal pain, fatigue, rash, pruritus, asthenia, cough, dyspnea, and pyrexia.
Sustained approval for nivolumab will depend upon confirmatory trials verifying and demonstrating clinical benefit.
- Bristol-Myers Squibb receives FDA approval for Opdivo (nivolulmab) in MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irintotecan [news release]. Princeton, NJ: Bristol-Myers Squibb; August 1, 2017. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-fda-approval-opdivo-nivolumab-ms. Accessed August 1, 2017.