The Food and Drug Administration (FDA) has approved an expanded indication for Yervoy (ipilimumab; Bristol-Myers Squibb) injection for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes >1mm who have undergone complete resection, including total lymphadenectomy.
The approval was based on improvement in recurrence-free survival (RFS) in a randomized, double-blind, placebo-controlled trial (n=951) patients with resected Stage IIIA (lymph node >1mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma. The study’s primary efficacy endpoint was RFS determined by an independent review committee.
Median RFS was 26 months in the ipilimumab arm vs. 17 months in the placebo arm (HR 0.75, 95% CI: 0.64, 0.90; P<0.002). Safety analysis showed that grade 3-5 immune mediated adverse reactions occurred in 41% of ipilimumab-treated patients; five treatment-related deaths were due to immune-mediated adverse reactions of enterocolitis, Guillain-Barre syndrome, and myocarditis.
Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody, is already approved for the treatment of unresectable or metastatic melanoma.
For more information call (800) 721-5072 or visit Yervoy.com.