FDA Approves First Drug for Multicentric Castleman's Disease
First Drug Approved for Multicentric Castleman's Disease
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.