Drug Name |
Brentuximab vedotin |
Drug ID |
BADD_D00291 |
Description |
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 [L1737].
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 [L1737].
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 [L1737].
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 [L1737].
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 [L1739]. |
Indications and Usage |
Seattle Genetics Announced FDA Approval of ADCETRIS® (Brentuximab Vedotin) in combination with chemotherapy for adults with previously untreated stage III or IV Classical Hodgkin Lymphoma in March 2018 [L1737, L1739].
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 [FDA label], [L1737].
Systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen [FDA label]. |
Marketing Status |
approved; investigational |
ATC Code |
L01FX05 |
DrugBank ID |
DB08870
|
KEGG ID |
D09587
|
MeSH ID |
D000079963
|
PubChem ID |
Not Available
|
TTD Drug ID |
D03TIS
|
NDC Product Code |
51144-050; 49187-0212; 69443-050; 78848-003 |
UNII |
7XL5ISS668
|
Synonyms |
Brentuximab Vedotin | cAC10-vcMMAE | cAC10 vcMMAE | cAC10vcMMAE | Adcetris | CAC10-1006 | CAC10 1006 | CAC101006 | SGN-35 | SGN 35 | SGN35 |