The European Commission, which has the authority to approve medicines for the European Union (EU), will now review the CHMP positive opinion.
Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "We are moving at a ground-breaking pace to deliver on a mission that looks to transform cancer treatment options for patients.
"Last month, we received a CHMP positive opinion for nivolumab for the treatment of advanced melanoma.
"Today’s announcement of a positive opinion for nivolumab in NSCLC brings us closer to delivering on our promise of changing the standard of care for lung cancer."
The positive opinion was based on data from CheckMate -017 and CheckMate -063, two trials that showed the efficacy and safety of nivolumab in patients with advanced or metastatic squamous NSCLC who had progressed following previous chemotherapy treatment.
The randomized, open-label Phase III CheckMate-017 trial included patients who had experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen.
The single-arm, multinational, multicenter Phase II CheckMate -063 trial included patients with metastatic squamous NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen.
In CheckMate -063, confirmed objective response rate, the study’s primary endpoint, was 14.5% (17/117) (95% CI = 8.7, 22.2) with an estimated one-year survival rate of 40.8% (95% CI: 31.6, 49.7) and median overall survival of 8.2 months (95% CI: 6.1, 10.9).
The company said that in both CheckMate -017 and -063, there was consistent nivolumab dosing of 3mg/kg every two weeks.