Examining the Impact of Opdivo’s Expanded Approval in Melanoma

Source: Cure Today, February 2016

The FDA granted an expanded approval to Opdivo (nivolumab) as a single agent and in combination with Yervoy (ipilimumab) on January 23 for the treatment of patients with melanoma who harbor BRAF V600 mutations. As a result of the expansion, Opdivo is now available as a frontline treatment for all patients with advanced melanoma, regardless of BRAF status.

The approval was based on the three-arm CheckMate-067 study, in which the dual checkpoint inhibitor combination reduced the risk of progression by 58 percent compared with Yervoy alone in patients with advanced melanoma. Single-agent Opdivo reduced the risk of progression by 43 percent versus Yervoy.

The trial randomized 945 patients with untreated unresectable or metastatic melanoma to receive Opdivo (316 patients), Yervoy (315 patients), or Opdivo plus Yervoy followed by Opdivo (314 patients).