This article is more than 5 years old. Information may no longer be current.

Health Canada approves Opdivo plus Yervoy for metastatic melanoma

Health Canada has granted conditional approval for Opdivo plus Yervoy for treating previously untreated adults with unresectable or metastatic BRAF V600 mutation-positive melanoma, according to a press release from Bristol-Myers Squibb Canada.

Health Canada also issued a notice of compliance with conditions for Opdivo (nivolumab) monotherapy for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in previously untreated adults, according to the release.

Data from the CheckMate -067 study was the basis of the latest approval, according to the release. The study compared progression-free survival and overall survival of nivolumab combined with Yervoy (ipilimumab) and of nivolumab monotherapy and of ipilimumab monotherapy in patients with previously untreated, resectable or metastatic melanoma.

The combination treatment of the nivolumab monotherapy resulted in significantly longer progression-free survival and higher response rates compared with treatment of ipilimumab alone, according to the release.

“Relative to [nivolumab] monotherapy, an increase in progression-free survival for the combination of [nivolumab] with [ipilimumab] is established only in patients with low tumor PD-L1 expression (based on the predefined expression level of < 5%),” Bristol-Myers Squibb Canada reported.

Reference: www.bmscanada.ca