Skip to main content
Premium Trial:

Request an Annual Quote

UK's NICE Recommends Approval of Opdivo, Yervoy for MSI-High, MMR-Deficient Colorectal Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence on Monday recommended approval of Bristol Myers Squibb's combination treatment of nivolumab (Opdivo) and ipilimumab (Yervoy) for microsatellite instability-high (MSI) or mismatch repair-deficient (dMMR) metastatic colorectal cancer patients after fluoropyrimidine-based combination chemotherapy.

Data from the Phase II CheckMate-142 trial showed that 55 percent of colorectal patients had an objective response on nivolumab-ipilimumab, and 84 percent achieved disease control at one year. The study also found that 76 percent of patients were progression-free at nine months and 71 percent at one year. In terms of overall survival, 87 percent of patients were alive at nine months and 85 percent were alive at one year on the dual immunotherapy regimen.

NICE said the cost of a 24 mL vial of a 240 mg dose of nivolumab is about £2,633 ($3,700) and the list price of ipilimumab is about £15,000 per 200 mg vial. BMS has offered nivolumab and ipilimumab to the UK's National Health Service at an undisclosed discount.

The US Food and Drug Administration granted accelerated approval to the combination in this indication in 2018. The European Medicines Agency also recommended approval in this setting in May.

Earlier this year, NICE also recommended approval for Merck's immunotherapy pembrolizumab (Keytruda) for MSI-high and dMMR, newly diagnosed metastatic colorectal cancer. Merck also received approval for pembrolizumab in this setting in Europe in January.