TriangleLABELS · a695c1a2-3acc-468b-a829-c8761dc041f6
ADCETRIS
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2025-11-11
- Captured
- 2026-09-09T23:37:54.830918+00:00
- Current indication reconciliation
- Not reconciled
Boxed warning in this label
- 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 ).
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ). • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide ( 1.2 ). • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation ( 1.3 ). • 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 ( 1.4 ). • Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone ( 1.5 ). • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen ( 1.6 ). • Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy ( 1.7 ). • Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product ( 1.8 ). 1.1 Previously Untreated Stage III or IV Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine. 1.2 Previously Untreated High Risk Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. 1.3 Classical Hodgkin Lymphoma (cHL) Consolidation ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. 1.4 Relapsed Classical Hodgkin Lymphoma (cHL) ADCETRIS is indicated for the treatment of adult patients with 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. 1.5 Previously Untreated Systemic Anaplastic Large Cell Lymphoma (sALCL) or Other CD30-Expressing Peripheral T-cell Lymphomas (PTCL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone. 1.6 Relapsed Systemic Anaplastic Large Cell Lymphoma (sALCL) ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. 1.7 Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-Expressing Mycosis Fungoides (MF) ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy. 1.8 Relapsed or Refractory Large B-Cell Lymphoma (LBCL) ADCETRIS in combination with lenalidomide and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy.
Full extracted label fields
- application numbers
- BLA125388
- boxed warning exact
- 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 ).
- brand names
- ADCETRIS
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3904f8dd-1aef-3490-e48f-bd55f32ed67f
- generic names
- BRENTUXIMAB VEDOTIN
- id
- a695c1a2-3acc-468b-a829-c8761dc041f6
- indications and usage exact
- 1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ). • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide ( 1.2 ). • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation ( 1.3 ). • 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 ( 1.4 ). • Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone ( 1.5 ). • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen ( 1.6 ). • Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy ( 1.7 ). • Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product ( 1.8 ). 1.1 Previously Untreated Stage III or IV Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV cHL, in combination with doxorubicin, vinblastine, and dacarbazine. 1.2 Previously Untreated High Risk Classical Hodgkin Lymphoma (cHL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. 1.3 Classical Hodgkin Lymphoma (cHL) Consolidation ADCETRIS is indicated for the treatment of adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. 1.4 Relapsed Classical Hodgkin Lymphoma (cHL) ADCETRIS is indicated for the treatment of adult patients with 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. 1.5 Previously Untreated Systemic Anaplastic Large Cell Lymphoma (sALCL) or Other CD30-Expressing Peripheral T-cell Lymphomas (PTCL), in Combination with Chemotherapy ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone. 1.6 Relapsed Systemic Anaplastic Large Cell Lymphoma (sALCL) ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. 1.7 Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-Expressing Mycosis Fungoides (MF) ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy. 1.8 Relapsed or Refractory Large B-Cell Lymphoma (LBCL) ADCETRIS in combination with lenalidomide and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory LBCL, including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or chimeric antigen receptor (CAR) T-cell therapy.
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- SEAGEN INC.
- matched search terms
- lymphoma
- lymphomas
- package ndcs
- 51144-050-01
- product ndcs
- 51144-050
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- Indications and Usage ( 1.8 ) 2/2025 Dosage and Administration ( 2.1 , 2.3 , 2.4 , 2.5 ) 2/2025 Warnings and Precautions ( 5.1 ) 2/2025
- record type
- complete_spl_indications_section_candidate
- routes
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- file
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- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
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Drugs@FDA application source records
- application number
- BLA125388
- payload
- all indexed label documents
- Appl No
- 125388
- Application Docs Date
- 2012-01-13 00:00:00
- Application Docs ID
- 18899
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf
- Submission No
- 5
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2014-11-25 00:00:00
- Application Docs ID
- 18900
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
- Submission No
- 56
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2014-11-25 00:00:00
- Application Docs ID
- 18901
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
- Submission No
- 78
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2015-08-17 00:00:00
- Application Docs ID
- 18902
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
- Submission No
- 80
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2011-08-19 00:00:00
- Application Docs ID
- 39948
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
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- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 125388
- Application Docs Date
- 2013-08-21 00:00:00
- Application Docs ID
- 39949
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf
- Submission No
- 45
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2015-08-17 00:00:00
- Application Docs ID
- 39950
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
- Submission No
- 81
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2016-03-08 00:00:00
- Application Docs ID
- 39951
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf
- Submission No
- 84
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2017-02-22 00:00:00
- Application Docs ID
- 47285
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf
- Submission No
- 88
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2017-11-09 00:00:00
- Application Docs ID
- 50348
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf
- Submission No
- 94
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2018-03-20 00:00:00
- Application Docs ID
- 53068
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf
- Submission No
- 97
- Submission Type
- SUPPL
- Appl No
- 125388
- Application Docs Date
- 2018-11-19 00:00:00
- Application Docs ID
- 56505
- Application Docs Title
- 0
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- 2
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- Submission No
- 99
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- 6
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- 2011-08-19 00:00:00
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- Appl No
- 125388
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- 11
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- 2012-01-13 00:00:00
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- Appl No
- 125388
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 45
- Submission Status
- AP
- Submission Status Date
- 2013-08-19 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 125388
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 56
- Submission Status
- AP
- Submission Status Date
- 2014-11-23 00:00:00
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- Appl No
- 125388
- Review Priority
- STANDARD
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- 3
- Submission No
- 78
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- 2014-11-23 00:00:00
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- Appl No
- 125388
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- Submission No
- 80
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- 2015-08-17 00:00:00
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- Appl No
- 125388
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- 3
- Submission No
- 81
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- 2015-08-17 00:00:00
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- Appl No
- 125388
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- 3
- Submission No
- 84
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- Submission Status Date
- 2016-03-04 00:00:00
- Submission Type
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- Appl No
- 125388
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 88
- Submission Status
- AP
- Submission Status Date
- 2016-09-28 00:00:00
- Submission Type
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- Appl No
- 125388
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- Submission Status Date
- 2017-11-09 00:00:00
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- Submissions Public Notes
- application number
- BLA125388
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
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- has approved submission record
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- latest approved submission date
- 2025-02-11
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 125388
- Application Docs Date
- 2025-02-12 00:00:00
- Application Docs ID
- 81217
- Application Docs Title
- 0
- Application Docs Type ID
- 2
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- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125388Orig1s108lbl.pdf
- Submission No
- 108
- Submission Type
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- official application record
- Appl No
- 125388
- Appl Public Notes
- Appl Type
- BLA
- Sponsor Name
- SEATTLE GENETICS
- openfda application present
- true
- products
- Active Ingredient
- BRENTUXIMAB VEDOTIN
- Appl No
- 125388
- Drug Name
- ADCETRIS
- Form
- INJECTABLE; INJECTION
- Product No
- 001
- Reference Drug
- 0
- Reference Standard
- Strength
- 50MG/VIAL
- marketing status
- Prescription
Source passages and status connections
Passage 1 · positive indication candidate
- application numbers
- BLA125388
- brand names
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- end exclusive
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- 1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ). • Pediatric patients 2 years and ol
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- source defined aliases
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- definition exact
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- 1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of:
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- Source null
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- Source null
- biomarker and test
- Source null
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- Source null
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- Source null
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- Source null
- prior therapy
- Source null
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- Source null
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- Source null
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Passage 2 · positive indication candidate
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- 1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ). • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide
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- untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone. 1.6 Relapsed Systemic Anaplastic Large Cell Lymphoma (sALCL) ADCETRIS is indicated for the treatment of adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. 1.7 Relapsed Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-Expressing Mycosis Fungoides (MF) ADCETRIS is indicated for the treatment of adult patients with pcALCL or CD30-expressi
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Preserved source evidence · Not medical advice