• 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
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • 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 » Adcetris (brentuximab vedotin)

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

Adcetris (brentuximab vedotin)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Adcetris (brentuximab vedotin) is an antibody-drug conjugate comprised of an anti-CD30 antibody joined by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. Brentuximab vedotin is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect.

    Adcetris is specifically approved for 1) Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and 2) systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

    Adcetris is supplied as a solution for intravenous infusion. The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every three weeks.

    Clinical Results

    FDA Approval
    Hodgkin Lymphoma
    The FDA approval of Adcetris for Hodgkin lymphoma was based on an open-label, single-arm, multicenter trial.The trial enrolled 102 subjects with HL who relapsed after autologous stem cell transplant. The subjects were treated with 1.8 mg/kg of Adcetris intravenously over 30 minutes every three weeks. Efficacy was based on overall response rate (ORR = complete remission [CR] + partial remission [PR]) and duration of response. The ORR was 73% and the median duration of response was 6.7 months.
    Systemic Anaplastic Large Cell Lymphoma
    The FDA approval of Adcetris for systemic anaplastic large cell lymphoma was based on an open-label, single-arm, multicenter trial. The trial enrolled 58 subjects who had relapsed after prior therapy. The subjects received 1.8 mg/kg of Adcetris administered intravenously over 30 minutes every three weeks. Efficacy was based on overall response rate (ORR = complete remission [CR] + partial remission [PR]) and duration of response. The ORR was 86% and the median duration of response was 12.6 months.

    Side Effects

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

    • neutropenia
    • peripheral sensory neuropathy
    • fatigue
    • nausea
    • anemia
    • upper respiratory tract infection
    • diarrhea
    • pyrexia
    • rash
    • thrombocytopenia
    • cough
    • vomiting

    Mechanism of Action

    Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent MMAE, and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10.

    Literature References

    Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. British Journal of Hematology 2009 Jul;146(2):171-9.

    Bartlett NL, Younes A, Carabasi MH, Forero A, Rosenblatt JD, Leonard JP, Bernstein SH, Bociek RG, Lorenz JM, Hart BW, Barton J A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood 2008 Feb 15;111(4):1848-54

    Additional Information

    For additional information regarding Adcetris or Hodgkin lymphoma and anaplastic large cell lymphoma, please visit the Adcetris web page.

    Approval Date: 2011-08-01
    Company Name: Seattle Genetics
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Virtual Doctoer

      Simple Changes Can Make Trials More Patient Friendly

    • Drug approval

      Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

    • VaccinewithNeedle-360x240.png

      Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

    • AskTheExperts-360x240.png

      Ask the Experts: Trial Operations Adjustments in a Remote World

    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 © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing