The FDA has granted accelerated approval to Opdivo (nivolumab) for the treatment of mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer.

Indications: Opdivo is a programmed death receptor-1 blocking antibody indicated for the treatment of patients 12 years and older with dMMR or MSI-H metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Dosage and administration: 240 mg every 2 weeks.

Efficacy and safety: Approval is based on a multicenter, open-label, single arm study involving 74 individuals showing an objective response rate of 28% in patients who received prior fluoropyrimidine, oxaliplatin, and irinotecan. Response lasted 6 or more months for two-thirds of these patients. There was 1 complete response and 14 partial responses. The objective response rate was 32% overall.

Adverse reactions: Most common adverse reactions are fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia.