Brentuximab vedotin

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

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
Associated Therapies
-

Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma

First Posted Date
2017-02-20
Last Posted Date
2024-07-15
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
62
Registration Number
NCT03057795
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 3 locations

Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

First Posted Date
2017-01-09
Last Posted Date
2024-02-22
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
29
Registration Number
NCT03013933
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery

First Posted Date
2016-12-30
Last Posted Date
2024-07-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
55
Registration Number
NCT03007030
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-12-09
Last Posted Date
2020-12-10
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
1
Registration Number
NCT02988843
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

First Posted Date
2016-12-01
Last Posted Date
2024-02-20
Lead Sponsor
Takeda
Target Recruit Count
59
Registration Number
NCT02979522
Locations
🇧🇷

ICr - Instituto da Crianca - HCFMUSP, Sao Paulo, Brazil

🇮🇹

Ospedale Pediatrico Bambino Gesu,UOC Onco-ematologia, Roma, Italy

🇧🇷

Hospital Santa Marcelina, Sao Paulo, Brazil

and more 11 locations

Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

First Posted Date
2016-10-19
Last Posted Date
2021-02-24
Lead Sponsor
Takeda
Target Recruit Count
39
Registration Number
NCT02939014
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

🇨🇳

Sun Yat-san University Cancer Center, Guangzhou, Guangdong, China

and more 4 locations

TSEB and Brentuximab for Treatment of Mycosis Fungoides & Sezary Syndrome

First Posted Date
2016-07-04
Last Posted Date
2019-08-30
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
5
Registration Number
NCT02822586
Locations
🇺🇸

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Alsertib (MLN8237) and Brentuximab Vedotin for Relapsed/Refractory CD30-Positive Lymphomas and Solid Malignancies

First Posted Date
2016-05-23
Last Posted Date
2018-07-27
Lead Sponsor
Eric Bernicker, MD
Registration Number
NCT02780011
Locations
🇺🇸

Houston Methodist Cancer Center, Houston, Texas, United States

Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma

First Posted Date
2016-05-02
Last Posted Date
2024-07-30
Lead Sponsor
Academic and Community Cancer Research United
Target Recruit Count
46
Registration Number
NCT02758717
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 6 locations
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