Janssen Biotech announced that the FDA has approved Sylvant (siltuximab) for the treatment of patients with multicentric Castleman’s disease (MCD) who are HIV negative and human herpesvirus-8 (HHV-8) negative. Sylvant is the first therapy approved for MCD in the US.
Sylvant is an interleukin-6 (IL-6) antagonist that binds to human IL-6, a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblasts and endothelial cells. Dysregulated overproduction of IL-6 from activated B cells in affected lymph nodes has been implicated in the pathogenesis of MCD.
Sylvant was evaluated in a multinational, randomized, double-blind, placebo-controlled study in 79 patients with MCD. The study showed that more than one-third of patients in the Sylvant arm had a durable tumor and symptomatic response to treatment plus best supportive care (BSC), compared to none of the patients who received placebo plus BSC (34% vs. 0%; 95% CI: 11.1, 54.8; P=0.0012). In addition, a 38% tumor response was seen for those in the Sylvant arm vs. 4% for those in the placebo arm (P<0.05).
Sylvant will be available as single-use vials in 100mg and 400mg strengths for IV infusion.
For more information call (800) 526-7736 or visit Sylvant.com.