FDA OKs Opdivo/Yervoy in Colon Cancer

FDA has approved Bristol Myers Squibb’s combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The agency says it also converted the accelerated approval to regular approval for single-agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

The combination use was approved based on data from the CHECKMATE-8HW (NCT04008030) trial that included a major efficacy outcome measure of progression-free survival. The most common adverse reactions reported in more than 20% of patients treated with nivolumab with ipilimumab were fatigue, diarrhea, pruritus, abdominal pain, musculoskeletal pain, and nausea.