The agency has granted priority review for this sBLA and is expected to respond by 30 September.
The new application is based on data from CheckMate -069, the first randomized trial evaluating the Opdivo+Yervoy.
In CheckMate -069, patients with BRAF gene wild-type mutation status treated with the regimen experienced improved objective response rate as compared to patients administered with Yervoy monotherapy.
According to the company, the Opdivo+Yervoy regimen achieved an objective response rate of 61%, including a 22% complete response rate, in previously untreated advanced melanoma patients.
Bristol-Myers Squibb senior vice-president and head of development, oncology Michael Giordano said: "Our strategy has always been to bring forth combination regimens of our Immuno-Oncology medicines to help bring the potential of long-term survival to patients.
"The Opdivo+Yervoy regimen, in the CheckMate -069 trial, demonstrated greater efficacy beyond standard of care for patients with advanced melanoma."
Both Opdivo and Yervoy are monoclonal antibodies and immune checkpoint inhibitors that target separate, distinct checkpoint pathways.