Brentuximab Vedotin
Monoclonal antibody targets TNFRSF8
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | ADCETRIS | — | 2015-08-17 – 2025-02-11 | fda.gov ↗ |
| Approved | EU (EMA) | Adcetris | — | 2012-10-25 | europa.eu ↗ |
| Approved | US (FDA) | ADCETRIS | — | 2011-08-19 | fda.gov ↗ |
Trials 171 · started per year
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02408042 Comparator | Apr → Nov 2015 | Hodgkins lymphoma, non-Hodgkin lymphoma | Western Regional Medical Center | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06563778 Comparator | Sep 2024 → Sep 2026 expected | classic Hodgkin lymphoma | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06393361 Comparator | Jun 2024 → Jun 2027 expected | classic Hodgkin lymphoma | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05180097 Comparator | Nov 2022 → Dec 2026 expected | classic Hodgkin lymphoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05253495 Background | Feb 2022 → Dec 2027 expected | Hodgkins lymphoma, non-Hodgkin lymphoma | New York Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT04138875 Comparator | Jan 2022 → Sep 2023 | classic Hodgkin lymphoma, infectious mononucleosis, post-transplant lymphoproliferative disease | Yale University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01569204 Comparator | Oct 2012 → Mar 2014 | Hodgkins lymphoma | University of Cologne | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02684292 Comparator | May 2016 → Jan 2026 | Hodgkins lymphoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT07258680 Comparator | Oct 2013 → Dec 2028 expected | peripheral T-cell lymphoma, not otherwise specified | N.N. Petrov National Medical Research Center of Oncology | Enrolling by invitation | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06761911 Comparator | Dec 2024 → Dec 2025 overdue | Hodgkins lymphoma | Xiuhua Sun | Not yet recruiting | No outcome recorded |
Press releases naming this drug 39 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-03 | Takeda | European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD takeda.com ↗ |
| 2025-02-12 | Pfizer | U.S. FDA Approves Pfizer’s ADCETRIS® Combination Regimen for the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma pfizer.com ↗ |
| 2024-06-01 | Takeda | Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma takeda.com ↗ |
| 2024-06-01 | Pfizer | Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma pfizer.com ↗ |
| 2024-06-01 | Pfizer | Pfizer’s ADCETRIS® Regimen Produces Clinically Meaningful Improvement in Overall Survival in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) pfizer.com ↗ |
| 2024-03-12 | Pfizer | Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) pfizer.com ↗ |
| 2023-10-18 | Takeda | European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD takeda.com ↗ |
| 2022-05-26 | Takeda | Takeda and Seagen to Highlight ADCETRIS ® Combination Data Showing Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma takeda.com ↗ |
| 2020-05-15 | Takeda | Takeda China announces ADCETRIS ® (brentuximab vedotin) is approved for the treatment of adult patients with CD30-positive Lymphomas takeda.com ↗ |
| 2020-05-14 | Takeda | European Commission Approves ADCETRIS ® (brentuximab vedotin) for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma takeda.com ↗ |
| 2020-03-31 | Takeda | Takeda Receives Positive CHMP Opinion for ADCETRIS ® (brentuximab vedotin) in Combination with CHP (Cyclophosphamide, Doxorubicin and Prednisone) for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma takeda.com ↗ |
| 2019-12-09 | Takeda | Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS ® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting takeda.com ↗ |
| 2019-02-11 | Takeda | European Commission Approves ADCETRIS ® (brentuximab vedotin) with AVD, the First New Treatment in Decades for Adults with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma takeda.com ↗ |
| 2018-12-14 | Takeda | Takeda Receives Positive CHMP Opinion for ADCETRIS ® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD takeda.com ↗ |
| 2018-12-04 | Takeda | Seattle Genetics and Takeda Present Positive Data from Phase 3 ECHELON-2 Clinical Trial for ADCETRIS ® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas takeda.com ↗ |
| 2018-10-01 | Takeda | Seattle Genetics and Takeda Announce Positive Results from Phase 3 ECHELON-2 Clinical Trial Evaluating ADCETRIS ® (Brentuximab Vedotin) in Frontline CD30-Expressing Peripheral T-Cell Lymphoma takeda.com ↗ |
| 2018-09-21 | Takeda | Takeda Obtains Additional Indication and Dosage & Administration for ADCETRIS ® as a Frontline Treatment for CD30-positive Hodgkin Lymphoma in Japan takeda.com ↗ |
| 2018-01-22 | Takeda | European Commission Approves ADCETRIS ® (brentuximab vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma after One Prior Systemic Therapy – Providing an Innovative Treatment Option to Patients takeda.com ↗ |
| 2017-12-10 | Takeda | Takeda and Seattle Genetics to Present Positive Data from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS ® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma takeda.com ↗ |
| 2017-11-14 | Takeda | Takeda Receives Positive CHMP Opinion for ADCETRIS ® (brentuximab vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma takeda.com ↗ |
| 2017-10-03 | Takeda | Seattle Genetics and Takeda Announce Publication in Blood of Final Long-Term Survival Data from ADCETRIS ® (Brentuximab Vedotin) Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma takeda.com ↗ |
| 2017-06-26 | Takeda | Takeda and Seattle Genetics Announce Positive Results from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS ® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma takeda.com ↗ |
| 2017-06-07 | Takeda | Takeda and Seattle Genetics Announce Lancet Publication of Phase 3 ALCANZA Clinical Trial Data of ADCETRIS® (Brentuximab Vedotin) for CD30-Positive Cutaneous T-Cell Lymphoma takeda.com ↗ |
| 2016-12-04 | Takeda | Takeda and Seattle Genetics Report Positive Phase 3 ALCANZA Clinical Trial Data of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma takeda.com ↗ |
| 2016-11-08 | Takeda | Seattle Genetics and Takeda Complete Enrollment of Phase 3 ECHELON-2 Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in Frontline Mature T-cell Lymphoma takeda.com ↗ |
| 2016-08-01 | Takeda | Takeda and Seattle Genetics Announce Positive Data from Phase 3 ALCANZA Clinical Trial of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma takeda.com ↗ |
| 2016-07-18 | Takeda | Seattle Genetics and Takeda Announce Publication of Final Data from ADCETRIS® (Brentuximab Vedotin) Monotherapy Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Classical Hodgkin Lymphoma in Blood takeda.com ↗ |
| 2016-07-06 | Takeda | Takeda Receives European Commission Approval of ADCETRIS® (brentuximab vedotin) for Consolidation Treatment in Post-Transplant Hodgkin Lymphoma takeda.com ↗ |
| 2016-05-27 | Takeda | Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) as Consolidation Treatment in Post-Transplant Hodgkin Lymphoma takeda.com ↗ |
| 2016-01-22 | Takeda | European Commission Approves Label Variation for ADCETRIS ® (Brentuximab Vedotin) to Include Data on Retreatment of Adult Patients with Relapsed or Refractory Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma (sALCL) takeda.com ↗ |
| 2015-12-23 | Bristol-Myers Squibb | Seattle Genetics and Bristol-Myers Squibb Announce Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Relapsed or Refractory Non-Hodgkin Lymphoma bms.com ↗ |
| 2015-12-07 | Takeda | Takeda Reports Five-Year Overall Survival Data For ADCETRIS® (Brentuximab Vedotin) Demonstrate Durable Remissions in Relapsed/Refractory Hodgkin Lymphoma takeda.com ↗ |
| 2015-10-28 | Takeda | Seattle Genetics and Takeda Achieve Target Enrollment in Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS ® (Brentuximab Vedotin) in Previously Untreated Advanced Hodgkin Lymphoma (HL) takeda.com ↗ |
| 2014-12-08 | Takeda | Seattle Genetics and Takeda Report Phase 3 AETHERA Clinical Trial Data from ADCETRIS ® (Brentuximab Vedotin) in Post-Transplant Hodgkin Lymphoma Patients at Risk of Relapse at ASH Annual Meeting takeda.com ↗ |
| 2014-12-08 | Takeda | Seattle Genetics and Takeda Announce Four-Year Survival Data from ADCETRIS ® (Brentuximab Vedotin) Pivotal Trial in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma at ASH Annual Meeting takeda.com ↗ |
| 2014-11-07 | Takeda | Takeda Announces Abstracts for ADCETRIS ® (brentuximab vedotin) in Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma and Ixazomib in Multiple Myeloma to be Presented at 56th American Society of Hematology Annual Meeting takeda.com ↗ |
| 2014-09-30 | Takeda | Seattle Genetics and Takeda Announce Positive Data from Phase 3 AETHERA Clinical Trial of ADCETRIS ® (Brentuximab Vedotin) for Consolidation in Post-Transplant Hodgkin Lymphoma takeda.com ↗ |
| 2014-04-17 | Takeda | "ADCETRIS ® 50mg for intravenous drip infusion", Treatment for Patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma or Relapsed or Refractory Anaplastic Large Cell Lymphoma Now Available in Japan takeda.com ↗ |
| 2014-01-17 | Takeda | Takeda Announces the New Drug Application Approval of ADCETRIS ® (brentuximab vedotin) in Japan for the Treatment of Malignant Lymphoma takeda.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 183 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | brentuximab vedotin | “Brentuximab Vedotin, 1.8mg/kg/dose, d0、Rituximab, 375 mg/m2, d0、Cyclophosphamide, 750 mg/m2, d1、Doxorubicin, 50 mg/m2, d1、Prednisone, 60mg/m2, d1-5” NCT06925555 ↗176“brentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2” NCT05253495 ↗ “Brentuximab Vedotin Etoposide Cyclophosphamide Doxorubicin Dacarbacine Dexamethasone” NCT06919679 ↗ “CD30 target immunotherapy:Brentuximab Vedotin or CD30-targeting CAR-T Cell Therapy.” NCT07138547 ↗ “Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.” NCT05006664 ↗ “1.2 mg/kg brentuximab vedotin i.v. on day 1 of a 21-day cycle” NCT03246750 ↗ |
| Known as | Adcetris | “Brentuximab vedotin, also known as Adcetris, is approved by the United States Food and Drug Administration (FDA) for treatment of certain types of lymphomas, including...” NCT03264131 ↗5“Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.” NCT05006664 ↗ “Brentuximab Vedotin (BV; Adcetris®) is an antibody-drug conjugate” NCT03187210 ↗ “Brentuximab vedotin (Adcetris)” NCT07013565 ↗ “Trade name: Adcetris” NCT01994850 ↗ |
| Known as | ADCETRIS (brentuximab vedotin) | “ADCETRIS (brentuximab vedotin)” NCT02533570 ↗ |
| Known as | Brentuximab | “This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration (FDA) has approved Brentuximab Vedotin for sale in the United States for certain...” NCT02588651 ↗1“Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin.” NCT01771107 ↗ |
| Known as | Brentuximab vedotin brentuximab | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Brentuximab vedotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Brentuximab vedotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | CAC-10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Cac10-1006(4) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | CAC10-VCMMAE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Cac10-vcmmae(4) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Monoclonal antibody sgn-30 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | Sgn 30 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742994 ↗ |
| Known as | SGN-35 | “This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study,...” NCT00947856 ↗5“In this study, instead of beginning with ICE chemotherapy, the patient will receive a new drug called Brentuximab vedotin (SGN-35).” NCT01508312 ↗ “Brentuximab vedotin (SGN-35)” NCT01868451 ↗ |
| Action | Deplete | “After the brentuximab vedotin attaches to the CD30 part of the cell, the MMAE enters the cell and kills it.” NCT01671813 ↗ |
| Modality | Monoclonal antibody | “Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells.” NCT01393717 ↗ |
| Route | Intravenous | “Patients with systemic ALCL and recurrent disease after at least one prior therapy received brentuximab vedotin 1.8 mg/kg intravenously every 3 weeks over 30 minutes as an...” PMID 22614995 ↗ May 2012 |
| Target | TNFRSF8 | “Tumor necrosis factor receptor superfamily member 8 binding agent” CHEMBL1742994 ↗ |