Opdivo Plus Yervoy Gets FDA OK for Melanoma

Source: MedPage Today, January 2016

WASHINGTON — Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.

The FDA based the approval on results of the phase III CheckMate-067 trial, which compared nivolumab plus the CTLA-4 inhibitor ipilimumab or nivolumab alone versus ipilimumab monothrapy. The trial involved 945 patients with previously untreated melanoma that was either unresectable or metastatic. Patients BRAF-wild type or BRAF-mutant were eligible.