Posted by Michael Wonder on 11 Jul 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) & low-dose Yervoy (ipilimumab) is the first immuno-oncology combination approved for MSI-H/dMMR mCRC patients who progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
11 July 2018 - Opdivo & Yervoy is now approved in three tumour types, dosing and administration varies by tumour.
Bristol-Myers Squibb today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. FDA for the treatment of adult and paediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
Today’s approved indication was based on data from the ongoing Phase 2 CheckMate-142 study evaluating the Opdivo + Yervoy combination in patients with MSI-H or dMMR mCRC previously treated with a fluoropyrimidine, oxaliplatin or irinotecan-based chemotherapy. The application was granted priority review and breakthrough therapy designation by the FDA.
