FDAnews
www.fdanews.com/articles/173861-fda-expands-approval-of-bms-melanoma-drug-yervoy

FDA Expands Approval of BMS’ Melanoma Drug Yervoy

November 3, 2015

The FDA last week approved an expanded use for Bristol-Myers Squibb’s Yervoy as adjuvant therapy to lower the risk of cancer returning after surgery in patients with stage 3 melanoma.

The FDA earlier this month approved a mixed-drug regimen of BMS’ Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced melanoma. The agency in 2011 approved Yervoy by itself as a treatment for stage 4 melanoma that cannot be removed by surgery.

Because of the potential for fatal immune-mediated adverse reactions and unusual severe side effects, Yervoy’s label includes a boxed warning.