US regulators have agreed to review a supplemental filing for Bristol-Myers Squibb’s combination of immunotherapies Opdivo and Yervoy in patients with previously untreated advanced melanoma.
The US Food and Drug Administration has assigned the application a priority review, on the back of data (from CheckMate-069) showing that the Opdivo (nivolumab)/Yervoy (ipilimumab) regimen achieved tumour shrinkage in 61% of patients and a complete response in 22%.
Opdivo and Yervoy are both US approved monoclonal antibodies and immune checkpoint inhibitors targeting separate, distinct checkpoint pathways, inhibition of which results in enhanced T cell function greater than the effects of either drug alone.
The FDA is set to make its decision by September 30.
