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
-

A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

First Posted Date
2015-10-28
Last Posted Date
2024-09-30
Lead Sponsor
Deepa Jagadeesh
Target Recruit Count
23
Registration Number
NCT02588651
Locations
🇺🇸

Wayne State University, Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

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

🇺🇸

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

and more 1 locations

An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

First Posted Date
2015-10-21
Last Posted Date
2023-03-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
145
Registration Number
NCT02581631
Locations
🇺🇸

Winship Cancer Institute., Atlanta, Georgia, United States

🇺🇸

University Of Chicago, Chicago, Illinois, United States

🇺🇸

Local Institution - 0003, New York, New York, United States

and more 24 locations

A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-10-08
Last Posted Date
2022-11-08
Lead Sponsor
Seagen Inc.
Target Recruit Count
93
Registration Number
NCT02572167
Locations
🇺🇸

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

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

and more 10 locations

A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-10-05
Last Posted Date
2018-05-11
Lead Sponsor
University of Birmingham
Target Recruit Count
38
Registration Number
NCT02567851
Locations
🇬🇧

University Hospital, Leicester, United Kingdom

🇬🇧

University Hospital of Wales, Cardiff, United Kingdom

🇬🇧

Norfolk and Norwich Hospital, Norwich, United Kingdom

and more 9 locations

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

First Posted Date
2015-08-27
Last Posted Date
2018-06-11
Lead Sponsor
Seagen Inc.
Target Recruit Count
20
Registration Number
NCT02533570
Locations
🇺🇸

Clayton Medical Associates, P.C., Saint Louis, Missouri, United States

🇺🇸

TriWest Research Associates, LLC, El Cajon, California, United States

🇺🇸

Lakes Research, LLC, Miami Lakes, Florida, United States

and more 14 locations

Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma

First Posted Date
2015-07-22
Last Posted Date
2020-08-24
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
34
Registration Number
NCT02505269
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting

First Posted Date
2015-07-16
Last Posted Date
2021-05-27
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Target Recruit Count
43
Registration Number
NCT02499627
Locations
🇮🇹

Spedali Civili, Brescia, BS, Italy

🇮🇹

AOU Città della Salute e della Scienza, Torino, TO, Italy

🇮🇹

IRCCS Fondazione Pascale, Napoli, Italy

and more 2 locations

Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-07-14
Last Posted Date
2022-03-22
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Target Recruit Count
25
Registration Number
NCT02497131
Locations
🇮🇹

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori, Milano, Italy

🇮🇹

SC Ematologia - Città della Salute e della Scienza, Torino, Italy

🇮🇹

A.O. Universitaria S. Maria Della Misericordia Di Udine, Udine, Italy

and more 1 locations

Brentuximab Vedotin and Imatinib in Patients With Relapsed or Refractory ALK+ ALCL

First Posted Date
2015-06-04
Last Posted Date
2022-03-03
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
3
Registration Number
NCT02462538
Locations
🇦🇹

Universitätsklinik f. Innere Medizin I, AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie, Wien, Austria

A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL

First Posted Date
2015-04-22
Last Posted Date
2017-06-26
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Target Recruit Count
15
Registration Number
NCT02423291
Locations
🇮🇹

Divisione di Ematologia Azienda Ospedaliera "Bianchi Melacrino Morelli", Reggio Calabria, RC, Italy

🇮🇹

Unità funzionale di Ematologia A.O.U. Careggi, Firenze, FI, Italy

🇮🇹

Dip. Oncologia, Ematologia e Patologie dell'apparato respiratorio A.O.U. Policlinico di Modena, Modena, MO, Italy

and more 6 locations
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