Opdivo is a human programed death receptor-1 (PD-1) blocking antibody indicated to treat this skin cancer.
The indication is approved under accelerated approval based on tumor response rate and durability of response.
Despite recent advances, there are limited treatment options available for patients with metastatic melanoma who have been previously treated with approved agents.
Bristol-Myers Squibb chief executive officer Lamberto Andreotti said: "Bristol-Myers Squibb is pleased to be able to offer an important new option for patients who have progressed following treatment for unresectable or metastatic melanoma, which is one of the most aggressive forms of cancer.
"The approval of Opdivo, the latest breakthrough medicine from our immuno-oncology pipeline, demonstrates our company’s commitment to meeting the needs of these patients, and to leading advances in the science of immuno-oncology."
According to the company, Opdivo is the only PD-1 that has showed efficacy in a pivotal Phase III clinical trial with advanced melanoma in patients who had been previously treated and progressed with Yervoy and, if BRAF mutation positive, a BRAF inhibitor.
The efficacy of Opdivo was assessed based on a single-arm, non-comparative planned interim analysis of the first 120 patients who received the drug with a minimum of six months follow-up in the Phase III CheckMate -037 trial.