The company is now allowed to use Opdivo in combination with Yervoy (ipilimumab) to treat unresectable or metastatic melanoma across BRAF mutational status.
The indication includes both BRAF-wild type and BRAF-mutant melanoma. The agency has also expanded the indication for single-agent Opdivo to include patients with previously untreated BRAF mutation-positive advanced melanoma patients.
In the CheckMate-067 study, the combination of Opdivo and Yervoy reduced the risk of progression by 58% compared with Yervoy alone in patients with advanced melanoma.
Single-agent Opdivo reduced the risk of progression by 43% versus Yervoy.
The approvals increase the number of Opdivo indications to seven, including four in melanoma, all granted since late 2014.
BMS head of US commercial Chris Boerner said: "CheckMate -067 is the first Phase 3 study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone.
"To make this treatment option available to more patients is truly a milestone in the fight against this deadly disease."
Last November, the FDA also approved Opdivo to treat patients with advanced renal cell carcinoma, who have received prior anti-angiogenic therapy.
Opdivo is also being assessed in combination with Seattle Genetics’ Adcetris (brentuximab vedotin) antibody-drug conjugate.
Image: Bristol-Myers Squibb site at Reeds Lane, Moreton, Wirral, England. Photo: courtesy of Rept0n1x.