FDA Approves New Treatment for Metastatic Colorectal Cancer
The US Food and Drug Administration granted accelerated approval to nivolumab (Opdivo) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability (MSI-H) metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
Nivolumab is recommended to be administered every 2 weeks at a dose of 240 mg.
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Approval was based on data from a multicenter, open-label, single arm study that included 53 adult patients with locally determined dMMR or MSI-H metastatic colorectal cancer (CRC) who had disease progression following fluoropyrimidine-based, oxaliplatin-based, and irinotecan-based chemotherapy. The objective response rate of patients who received nivolumab following prior chemotherapy was 28%, and 67% of participants had responses that lasted 6 months or more. One participant experienced complete response to treatment, and 14 experienced partial responses to treatment. The efficacy of nivolumab for adolescent patients was extrapolated from the results of the adult patients. Trials have not been conducted in pediatric patients.
Common adverse reactions associated with nivolumab included fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia.
FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer [press release]. FDA. July 31, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm. Accessed August 1, 2017.