ADCETRIS (brentuximab vedotin)
ADCETRIS is indicated for the treatment of Classical Hodgkin Lymphoma; Systemic Anaplastic Large Cell Lymphoma; Peripheral T-Cell Lymphoma; Angioimmunoblastic T-Cell Lymphoma; Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-08-19
- Patent Cliff
- 2029
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ADCETRIS Approval History
What ADCETRIS Treats
6 indicationsADCETRIS is approved for 6 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Classical Hodgkin Lymphoma
- Systemic Anaplastic Large Cell Lymphoma
- Peripheral T-Cell Lymphoma
- Angioimmunoblastic T-Cell Lymphoma
- Primary Cutaneous Anaplastic Large Cell Lymphoma
- Mycosis Fungoides
ADCETRIS Boxed Warning
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9) , Adverse Reactions (6.1) ] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning. JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS ( 5.9 , 6.1 )....
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9) , Adverse Reactions (6.1) ] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning. JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS ( 5.9 , 6.1 ).
ADCETRIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ADCETRIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ADCETRIS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ADCETRIS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
137 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07572123 | NCI-2026-03186 NCI-2026-03186, EA4241 | Ph 2, Ph 3 | not yet recruiting | Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT01896999 | NCI-2013-01275 NCI-2013-01275, E4412 | Ph 1, Ph 2 | active not recruiting | Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT05675410 | NCI-2022-10845 NCI-2022-10845, AHOD2131 | Ph 3 | recruiting | A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab |
| NCT01703949 results posted | 7808 NCI-2012-01696, 7808 | Ph 2 | active not recruiting | Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma |
| NCT01920932 results posted | HLHR13 NCI-2013-01123 | Ph 2 | active not recruiting | Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma |
| NCT03222492 BRAVOS results posted | DAIT ITN075AI UM1AI109565, NIAID CRMS ID#: 38418 | Ph 1, Ph 2 | completed | Brentuximab Vedotin for Systemic Sclerosis |
| NCT02166463 results posted | NCI-2014-01223 NCI-2014-01223, s15-00950 | Ph 3 | active not recruiting | Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma |
| NCT03907488 results posted | NCI-2019-01960 NCI-2019-01960, S1826 | Ph 3 | active not recruiting | Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma |
| NCT03057795 results posted | 16378 NCI-2017-00222, 16378 | Ph 2 | active not recruiting | Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma |
| NCT06377566 | 24-039 | Ph 2 | recruiting | A Study of BV-AVD in People With Bulky Hodgkin Lymphoma |
| NCT07275216 | 24081 NCI-2025-08524, 24081 | Ph 2 | recruiting | Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment |
| NCT03755804 | cHOD17 NCI-2018-02924 | Ph 2 | active not recruiting | Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 |
| NCT04404283 ECHELON-3 | SGN35-031 C5691003, 2023-503384-41-00 | Ph 3 | active not recruiting | Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL |
| NCT05922904 | 2022-0492 NCI-2023-05028 | Ph 2 | active not recruiting | PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma |
| NCT05414500 | IRB-300006649 (UAB2109) 000535246, 000533654 | Ph 1 | recruiting | Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides |
| NCT03587844 | 18-147 | Ph 2 | recruiting | Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients |
| NCT04685616 RADAR | RADAR 2020-005160-65, IISR X25041 | Ph 3 | recruiting | Brentuximab Vedotin in Early Stage Hodgkin Lymphoma |
| NCT04609566 | SGN35-033 C5691005 | Ph 2 | completed | Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors |
| NCT03652441 | Uni-Koeln 3263 2018-000873-59 | Ph 2 | completed | Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma |
| NCT01712490 results posted | C25003 2011-005450-60, U1111-1161-4937 | Ph 3 | completed | A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma |
| NCT06831370 | C25030 | Ph 4 | recruiting | A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India |
| NCT04745949 PACIFIC | 2020-0686 NCI-2020-13888, 2020-0686 | Ph 2 | recruiting | PACIFIC: Primary Mediastinal Large B-cell Lymphoma Treated With Antibody Therapy, Checkpoint Inhibitor in Frontline With ImmunoChemotherapy |
| NCT02684292 | 3475-204 163337, MK-3475-204 | Ph 3 | completed | Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204) |
| NCT04569032 results posted | SGN35-032 | Ph 2 | completed | A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression |
| NCT05180097 | HD11 | Ph 2 | recruiting | Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma |
| NCT05357794 | 2021-0500 NCI-2022-03831 | Ph 2 | recruiting | Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides |
| NCT02588651 results posted | CASE1415 | Ph 2 | completed | A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) |
| NCT02227199 BV-ICE results posted | 9111 NCI-2014-01782, 9111 | Ph 1, Ph 2 | completed | Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT03113500 results posted | 17058 NCI-2017-00573, 17058 | Ph 2 | active not recruiting | Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma |
| NCT02979522 results posted | C25004 2015-004112-38, U1111-1171-0984 | Ph 1, Ph 2 | active not recruiting | A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma |
| NCT03007030 | 2016-0514 NCI-2017-00069, 2016-0514 | Ph 2 | recruiting | Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery |
| NCT07002216 BrECADD | 20250293 | Ph 2 | recruiting | BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma |
| NCT03233347 | ACCRU-LY-1601 NCI-2017-01308, ACCRU-LY-1601 | Ph 2 | active not recruiting | Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma |
| NCT04561206 | 20147 NCI-2020-05332, 20147 | Ph 2 | recruiting | Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma |
| NCT01909934 results posted | C25006 2012-004128-39, U1111-1154-9784 | Ph 4 | completed | Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma |
| NCT05442554 results posted | C25029 | Ph 4 | completed | A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma |
| NCT02758717 results posted | RU051505I NCI-2016-00468, RU051505I | Ph 2 | active not recruiting | Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma |
| NCT03646123 results posted | SGN35-027 | Ph 2 | terminated | Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma |
| NCT05039073 | STUDY00002348 NCI-2021-01655, WINSHIP5260-21 | Ph 2 | recruiting | Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors |
| NCT01771107 results posted | NCI-2013-00046 NCI-2013-00046, 2014-003678-18 | Ph 1, Ph 2 | completed | Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma |
| NCT02734771 BV mini CHP | ULYM15105 IST-2014-100578 | Ph 2 | active not recruiting | A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT03517137 COBRA results posted | EORTC-1537-LYMG | Ph 2 | active not recruiting | Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study |
| NCT03409432 | OSU-17204 NCI-2017-02221 | Ph 2 | completed | Brentuximab Vedotin and Lenalidomide in Treating Patients With Stage IB-IVB Relapsed or Refractory T-Cell Lymphoma |
| NCT05673785 | C25024 | Ph 2 | active not recruiting | A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) |
| NCT04587687 | UCDCC#284 NCI-2020-06645, UCDCC#284 | Ph 2 | recruiting | Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma |
| NCT02616965 | HM-085 16-1009 | Ph 1 | completed | A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma |
| NCT03187210 BAL | BAL-Trial | Ph 1, Ph 2 | suspended | Brentuximab Vedotin and BeEAM High-dose Chemotherapy in Lymphomas |
| NCT02744612 results posted | 15334 NCI-2016-00176, 15334 | Ph 2 | completed | Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma |
| NCT05313243 | 2000029793 No NIH funding | Ph 2 | recruiting | Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma |
| NCT03264131 results posted | LCCC1637 | Ph 2 | active not recruiting | BV-CHEP Chemotherapy for Adult T-cell Leukemia or Lymphoma |
Showing 50 of 137 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADCETRIS FDA Label Details
Indications & Usage
FDA Label (PDF)ADCETRIS is indicated for the treatment of Classical Hodgkin Lymphoma; Systemic Anaplastic Large Cell Lymphoma; Peripheral T-Cell Lymphoma; Angioimmunoblastic T-Cell Lymphoma; Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides.
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9) , Adverse Reactions (6.1) ] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing informatio...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment