MedPath

Brentuximab vedotin

Generic Name
Brentuximab vedotin
Brand Names
Adcetris
Drug Type
Biotech
CAS Number
914088-09-8
Unique Ingredient Identifier
7XL5ISS668

Overview

Brentuximab vedotin, also known as Adcetris®, is an antibody-drug conjugate that combines an anti-CD30 antibody with the drug monomethyl auristatin E (MMAE). It is an anti-neoplastic agent used in the treatment of Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin was initially approved in 2011. In January 2012, the drug label was revised with a boxed warning of a condition known as progressive multifocal leukoencephalopathy and death due to opportunistic JC virus infection post treatment . The U.S. Food and Drug Administration approved Adcetris in March 2018 to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy . Adcetris has also been previously approved by the FDA to treat Hodgkin's lymphoma after relapse, Hodgkin's lymphoma after stem cell transplantation when a patient has a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after the failure of other treatment regimens, and primary cutaneous ALCL after failure of other treatment regimens . Lymphoma is a malignancy that begins in the lymphatic system, which helps to combat infection and disease. Lymphoma may begin anywhere in the body and can spread to nearby lymph nodes. The two main types of lymphoma are Hodgkin lymphoma (also called Hodgkin disease) and non-Hodgkin lymphoma. Most individuals with Hodgkin's lymphoma have the classical type. In this type of lymphoma, large, abnormal lymphocytes (a type of white blood cell) are found in the lymph nodes called Reed-Sternberg cells. With early diagnosis and intervention, patients with Hodgkin lymphoma normally experience long-term remission . The ECHELON-1 study results demonstrated superior efficacy of the drug combined with a chemotherapy regimen when it is compared to the previous standard of care. Importantly, removing the drug bleomycin, a highly toxic agent, was completely removed from the regimen. This demonstrates meaningful progress in treatment for patients affected by this disease .

Indication

Brentuximab vedotin is indicated in adult patients for the treatment of previously untreated stage III or IV classical Hodgkin's lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine. It is also indicated for the treatment of cHL post-autologous hematopoietic stem cell transplantation (auto-HSCT) in patients at high risk of relapse or progression. Finally, it may be used in the treatment of adult patients with cHL who have previously failed either auto-HSCT or at least two prior multi-agent chemotherapy regimens if they are not candidates for auto-HSCT. Brentuximab vedotin is additionally indicated in the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL), or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with cyclophosphamide, doxorubicin, and prednisone. It may also be used as monotherapy in sALCL after therapeutic failure of a least one prior multi-agent chemotherapy regimen. Brentuximab vedotin is also indicated in the treatment of primary cutaneous large anaplastic large cell lymphoma, or CD30-expressing mycosis fungoides, who have received prior systemic therapy.

Associated Conditions

  • CD30-expressing Mycosis Fungoides (MF)
  • Classical Hodgkin's Lymphoma
  • Peripheral T-Cell Lymphoma (PTCL)
  • Primary Cutaneous Anaplastic Large Cell Lymphoma
  • Systemic Anaplastic Large Cell Lymphoma
  • Stage 3 Classical Hodgkin's Lymphoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/03
Phase 2
Recruiting
2025/02/18
Phase 4
Recruiting
2025/01/07
Phase 4
Not yet recruiting
Xiuhua Sun
2024/08/21
Phase 2
Not yet recruiting
Chinese PLA General Hospital
2024/08/20
Phase 2
Recruiting
Children's Cancer Group, China
2024/05/01
Phase 2
Recruiting
Chinese PLA General Hospital
2024/04/22
Phase 2
Recruiting
2024/01/11
Phase 2
ENROLLING_BY_INVITATION
Beijing Children's Hospital
2024/01/02
Phase 3
Not yet recruiting
2023/06/28
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
SEAGEN INC.
51144-050
INTRAVENOUS
50 mg in 10.5 mL
6/22/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
10/25/2012

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ADCETRIS® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL
SIN14477P
INJECTION, POWDER, FOR SOLUTION
50mg/vial
1/8/2014

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Brentuximab Vedotin for Injection
国药准字SJ20200008
生物制品
注射剂
2/7/2025
Brentuximab Vedotin for Injection
S20200008
生物制品
注射剂
5/12/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
ADCETRIS brentuximab vedotin (rch) 50 mg powder for injection vial
203372
Medicine
A
12/20/2013

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