Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 | US First approvals for: Hodgkin Lymphoma (ADCETRIS is indicated for the treatment of patients with 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.); Anaplastic Large Cell Lymphoma (ADCETRIS is indicated for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.). US supplemental approvals [as of June 14, 2024 label] for: classical Hodgkin Lymphoma (cHL) (ADCETRIS is indicated for treatment of: Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine; or, Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide; or, Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation; or, Adult patients with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates); Anaplastic Large Cell Lymphoma (ADCETRIS is indicated for treatment of Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral Tcell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone; or Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen; or, Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy). EU: First approval for Hodgkin lymphoma and for Systemic anaplastic large cell lymphoma (ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1) following autologous stem cell transplant (ASCT), or 2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL)). Supplemental approvals for: Hodgkin lymphoma (ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) or, ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) or, ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1) following ASCT, or 2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.); Systemic anaplastic large cell lymphoma (ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or, ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.); Cutaneous T-cell lymphoma (ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy) [as per EPAR - Product information last updated on December 1, 2023]. |
| 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 |