The Food and Drug Administration has granted accelerated approval to checkpoint inhibitor nivolumab for the treatment of patients with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
The indication covers patients aged 12 years and older. Efficacy for adolescent patients with MSI-H or dMMR metastatic CRC is extrapolated from the results in the respective adult population, the FDA said in a statement.
Approval of nivolumab in the adult population was based on an objective response rate of 28% in CHECKMATE 142, an open-label, single-arm study of 53 patients with locally determined dMMR or MSI-H metastatic CRC who had disease progression during, after, or were intolerant to prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Responses lasted 6 or more months for 67% of patients.
The most common adverse reactions to nivolumab, marketed as Opdivo by Bristol-Myers Squibb, include fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia, the FDA said.
The recommended nivolumab dose is 240 mg every 2 weeks.