FDA/CDC

FDA grants accelerated approval to ipilimumab/nivolumab combo for CRC


 

The Food and Drug Administration has granted accelerated approval to ipilimumab (Yervoy) for the treatment of colorectal cancer (CRC) in patients aged 12 years and older, in combination with nivolumab (Opdivo). Specifically, this indication is for microsatellite instability–high or mismatch repair deficient metastatic CRC that has progressed after treatment with a fluoropyrimidine, oxaliplatin, or irinotecan, the FDA said in a press announcement.

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This new use has been added to the nivolumab labeling; nivolumab received an accelerated approval of its own on July 31, 2017, as a single-agent treatment for these kinds of CRCs.

These approvals were based on the overall response rate in the nonrandomized CheckMate 142 trial. In the multiple parallel-cohort, open-label study, 82 patients received 1 mg/kg of IV ipilimumab and 3 mg/kg of IV nivolumab every 3 weeks for four doses, followed by 3 mg/kg of IV nivolumab alone every 2 weeks until either radiographic progression or unacceptable toxicity.

Their overall response rate was 46%, and 89% of those responding had response durations greater than 6 months. These rates were higher than those observed in a separate cohort of 58 patients who received only nivolumab: 28% and 67%, respectively.

The most common adverse events were fatigue, diarrhea, pyrexia, musculoskeletal pain, abdominal pain, pruritus, nausea, rash, dyspnea, decreased appetite, and vomiting.

Full prescribing information for ipilimumab and nivolumab can be found on the FDA website.

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