Sylvant(siltuximab)

Immunology· 482 cited findings· 1 source document

Company: Recordati B V

What the regulatory reviews say

Sylvant (siltuximab) is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. It is available in strengths of 100 mg and 400 mg. The Marketing Authorisation application was submitted on 29 August 2013 by Janssen-Cilag International NV. Sylvant received orphan medicinal product designation on 30 November 2007 for the treatment of Castleman’s disease.

In efficacy studies, siltuximab treatment resulted in a 47% decrease in hepcidin, compared to an 11% increase in the placebo group. An improvement in one or more components of clinical benefit assessments was observed in 86.5% of patients. The overall tumor response rate, as determined by independent review, was 37.7%, with a difference of 33.9% compared to a comparator arm. Investigator assessment showed a best tumor response rate of 50.9%.

Safety findings included a maximum change from baseline in QTcF or QTcB of 30 msec. In toxicology studies, a maximum dose level of 46 mg/kg was administered, with an exposure ratio (Cmax) of 7-fold and an exposure ratio (AUC) of 20-fold compared to clinical exposure. Skin erythema and facial swelling were observed at a dose of 46 mg/kg.

Key figures — cited to the source page

Hepcidin decrease post siltuximab treatment	47 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.34
Hepcidin increase in placebo group	11 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.34
Improvement in 1 or more components of clinical benefit assessments	86.5 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.38
Overall tumour response rate (independent review)	37.7 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.50
Difference in overall tumour response rate (independent review)	33.9 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.50
Best tumour response rate (investigator assessment)	50.9 %	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.50
Maximum change from baseline in QTcF or QTcB	30 msec	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.35
Exposure ratio (AUC) compared to clinical	20 fold	Recordati B V — Sylvant EMA EPAR public assessment report (E, p.27

Source documents

Recordati B V — Sylvant EMA EPAR public assessment report (EMEA/H/C/003708, 2014) (2014)

Explore the full evidence

All 482 cited findings for Sylvant — searchable, comparable and answerable in plain language — are in the Immunology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.