• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Sylvant (siltuximab)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Sylvant (siltuximab)

  • Profile

Profile

Contact Information

Contact: EUSA Pharma
Website: https://www.sylvant.com/en-us

Currently Enrolling Trials

    Show More

    General Information

    Sylvant (siltuximab) is an anti-interleukin-6 (IL-6) chimeric monoclonal antibody that binds to human IL-6.1 IL-6 is 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, or mechanism causing, multicentric Castleman's disease.

    Sylvant is specifically indicated for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

    Mechanism of Action

    Sylvant (siltuximab) binds human IL-6 and prevents the binding of IL-6 to both soluble and membrane-bound IL-6 receptors. IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion. Overproduction of IL-6 has been linked to systemic manifestations in patients with MCD.

    Side Effects

    Adverse effects associated with the use of Sylvant may include, but are not limited to, the following:

    • pruritus
    • increased weight
    • rash
    • hyperuricemia
    • upper respiratory tract infection

    Dosing/Administration

    Sylvant is supplied as a solution for intravenous infusion. The recommended dose is 11 mg/kg is given over one hour as an intravenous infusion administered every three weeks until treatment failure.

    Clinical Trial Results

    The FDA approval of Sylvant was based on a phase I2, multinational, randomized, double-blind, placebo-controlled study. In this study, 53 subjects were randomized to best supportive care (BSC) and Sylvant at a dose of 11 mg/kg every three weeks and 26 subjects were randomized to BSC and placebo. Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity. The major efficacy outcome of the study was durable tumor and symptomatic response, defined as tumor response assessed by independent review and complete resolution or stabilization of MCD symptoms. A durable response was defined as tumor and symptomatic response that persisted for a minimum of 18 weeks without treatment failure. The durable tumor and symptomatic response in the Sylvant arm was 34 percent compared to 0 percent in the placebo arm (p=0.0012).

     

    Approval Date: 2014-04-01
    Company Name: Janssen Biotech
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing