TAbS







Brentuximab vedotin Approved ADC

Antibody Information

Entry ID 147
INN Brentuximab vedotin
Status Approved
Drug code(s) SGN-35
Brand name Adcetris
mAb sequence source mAb chimeric
General Molecular Category ADC
Format, general category Full length Ab conjugate
Format details None
Isotype (Fc) IgG1
Light chain isotype kappa
Linker Valine-Citrulline, Cleavable linker
Ave. DAR 4
Conjugated/fused moiety Tubulin inhibitor, Monomethyl auristatin E (MMAE)
Discovery method/technology None

Therapeutic information

Target(s) CD30
Indications of clinical studies Hodgkin's lymphoma, anaplastic large cell lymphoma, germ cell tumors, mesothelioma, lymphatic diseases, systemic lupus erythematosus
Primary therapeutic area Cancer

Development stage information


Most advanced stage of development (global) Approved EU, US, Japan, Australia
Status Active
Start of clinical phase (IND filing or first Phase 1) November 15, 2006
Start of Phase 2 February 15, 2009
Start of Phase 3 April 15, 2010
Date BLA/NDA submitted to FDA February 28, 2011
Year of first approval (global) 2011
Date of first US approval August 19, 2011
INN, US product name Brentuximab vedotin
US or EU approved indications Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma, Cutaneous T-Cell Lymphoma, treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma

Company information

Company Seattle Genetics
Licensee/Partner None
Comments about company or candidate US orphan; Fast track
Full address of company 21823 30Th Dr Se Bothell, WA 98021, United States
North America
United States of America
https://www.sbir.gov/node/302736

Description/comment

Cysteine conjugated ADC

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None