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 |
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 |
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 | 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 |
Cysteine conjugated ADC
Anticipated events | None |
Factor(s) contributing to discontinuation | None |