Brentuximab vedotin
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Brentuximab vedotin
- adcetris
- Adcetris
- adcetris
- adcetris 50 mg injection
- Adcetris 50 MG Injection
- Adcetris-Levact
- BRENTUXIMAB [VANDF]
- brentuximab vandf
- brentuximab vedotin
- Brentuximab vedotin
- Brentuximab Vedotin
- BRENTUXIMAB VEDOTIN
- Brentuximab vedotin (Adcetris)
- Brentuximab Vedotin (Bv)
- BRENTUXIMAB VEDOTIN (GENETICAL RECOMBINATION)
- brentuximab vedotin (SGN-35)
- Brentuximab vedotin (SGN-35)
- Brentuximab Vedotin (SGN-35)
- brentuximab vedotin [INN]
- BRENTUXIMAB VEDOTIN [JAN]
- BRENTUXIMAB VEDOTIN [MART.]
- BRENTUXIMAB VEDOTIN [MI]
- BRENTUXIMAB VEDOTIN [PURPLE BOOK CDER]
- BRENTUXIMAB VEDOTIN [USAN]
- BRENTUXIMAB VEDOTIN [VANDF]
- Brentuximab vedotin [WHO-DD]
- brentuximab vedotin brentuximab
And 35 more, listed on the interactive page.
- ATC classification codes
- L01FX05
Sources for recorded values
- CAS registry numbers
- 914088-09-8
- ChEMBL ID
- CHEMBL1742994
- RxNorm IDs (RxCUI)
- 1147320
- FDA ingredient codes (UNII)
- 7XL5ISS668
- Applicant
- SEATTLE GENETICS
- Approval date
- 19 Aug 2011
- Application number
- BLA125388
- Status
- Authorised
- Status date
- 25 Oct 2012
- Authorisation date
- 25 Oct 2012
- Approved indications
- Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).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).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):- following ASCT, or- following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T-cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.
- Product number
- EMEA/H/C/002455
- Authorisation holder
- Takeda Pharma A/S
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 10 Nov 2029
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- brentuximab vedotin
- Type
- Antibody
- Drug name stem
- -dotin; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Tumor necrosis factor receptor superfamily member 8 binding agent
- Action type
- BINDING_AGENT
- Target
- Tumor necrosis factor receptor superfamily member 8
- Protein identifier
- P28908
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CD30
- Gene symbol
- TNFRSF8
- Protein identifier
- P28908
- Primary target
- Yes
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Mechanism
- Tumor necrosis factor receptor superfamily member 8 binding agent
- Action type
- BINDING AGENT
- Target
- Tumor necrosis factor receptor superfamily member 8
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Hodgkin Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Scleroderma, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000404
- Subject identifier
- D045743
- Condition
- Neoplasms, Germ Cell and Embryonal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000514
- Subject identifier
- D009373
- Condition
- Leukemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001642
- Subject identifier
- D019337
- Condition
- Lymphoma, T-Cell, Cutaneous
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002913
- Subject identifier
- D016410
- Condition
- Lymphoma, Large-Cell, Anaplastic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003032
- Subject identifier
- D017728
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Leukemia, Mast-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007359
- Subject identifier
- D007946
- Condition
- Mesothelioma, Malignant
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000355
- Subject identifier
- D000086002
- Condition
- Sezary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000785
- Subject identifier
- D012751
- Condition
- Mycosis Fungoides
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001051
- Subject identifier
- D009182
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000430
- Subject identifier
- D016411
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
- Condition
- Hodgkin Disease
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0009348
- Subject identifier
- D006689
- Condition
- Graft vs Host Disease
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0013730
- Subject identifier
- D006086
- Condition
- Mastocytosis, Systemic
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0016586
- Subject identifier
- D034721
And 3 more, listed on the interactive page.
- Condition identifier
- EFO_0000183
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000404
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000514
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000638
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001642
- Condition identifier
- EFO_0002913
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003032
- Condition identifier
- EFO_0004920
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005952
- Condition identifier
- EFO_0007352
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007359
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000341
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000355
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001051
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000607
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004952
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004964
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005019
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005040
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
And 22 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- anaplastic large cell lymphoma t- and null-cell types
- Reports
- 14
- Reporting signal score
- 61.7945
- Event
- anaplastic large-cell lymphoma
- Reports
- 26
- Reporting signal score
- 130.852
- Event
- cutaneous t-cell lymphoma
- Reports
- 12
- Reporting signal score
- 39.3533
- Event
- cytomegalovirus chorioretinitis
- Reports
- 35
- Reporting signal score
- 114.579
- Event
- cytomegalovirus infection
- Reports
- 35
- Reporting signal score
- 44.8587
- Event
- disease progression
- Reports
- 120
- Reporting signal score
- 113.916
- Event
- dizziness
- Reports
- 14
- Reporting signal score
- 44.2414
- Event
- drug hypersensitivity
- Reports
- 3
- Reporting signal score
- 41.9431
- Event
- endocarditis noninfective
- Reports
- 11
- Reporting signal score
- 53.9494
- Event
- febrile neutropenia
- Reports
- 259
- Reporting signal score
- 483.295
- Event
- guillain-barre syndrome
- Reports
- 26
- Reporting signal score
- 53.6437
- Event
- headache
- Reports
- 24
- Reporting signal score
- 41.0392
- Event
- hodgkin's disease
- Reports
- 165
- Reporting signal score
- 690.472
- Event
- hodgkin's disease recurrent
- Reports
- 20
- Reporting signal score
- 106.272
- Event
- hodgkin's disease refractory
- Reports
- 32
- Reporting signal score
- 189.858
- Event
- infusion related reaction
- Reports
- 62
- Reporting signal score
- 43.3535
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 37.4366
- Event
- malignant neoplasm progression
- Reports
- 68
- Reporting signal score
- 53.8244
- Event
- neuropathy peripheral
- Reports
- 217
- Reporting signal score
- 318.151
- Event
- neutropenia
- Reports
- 195
- Reporting signal score
- 178.087
- Event
- neutrophil count decreased
- Reports
- 71
- Reporting signal score
- 79.7276
- Event
- pancytopenia
- Reports
- 66
- Reporting signal score
- 52.3076
- Event
- peripheral motor neuropathy
- Reports
- 27
- Reporting signal score
- 87.4559
- Event
- peripheral sensory neuropathy
- Reports
- 53
- Reporting signal score
- 125.46
- Event
- peripheral t-cell lymphoma unspecified
- Reports
- 16
- Reporting signal score
- 65.0747
And 5 more, listed on the interactive page.
- NCT00848926
- NCT00947856
- NCT01060904
- NCT01100502
- NCT01393717
- NCT01492088
- NCT01508312
- NCT01534078
- NCT01569204
- NCT01712490
- NCT01716806
- NCT01780662
- NCT01874054
- NCT01902160
- NCT01920932
- NCT01950364
- NCT01990534
- NCT02098512
- NCT02164006
- NCT02166463
- NCT02191930
- NCT02227199
- NCT02227433
- NCT02244021
- NCT02254239
And 100 more, listed on the interactive page.
- Dose
- 1.8 mg/kg
- Route
- Intravenous infusion
- How often
- Every 3 weeks
Conditions of use
- Administer over 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVLTQSPASLAVSLGQRATISCKASQSVDFDGDSYMNWYQQKPGQPPKVLIYAASNLESGIPARFSGSGSGTDFTLNIHPVEEEDAATYYCQQSNEDPWTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QIQLQQSGPEVVKPGASVKISCKASGYTFTDYYITWVKQKPGQGLEWIGWIYPGSGNTKYNEKFKGKATLTVDTSSSTAFMQLSSLTSEDTAVYFCANYGNYWFAYWGQGTQVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- 51144-050
Related records
Trials (191)
- A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
- A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
- A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
- A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
- A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
- A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
- A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
- A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
- A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
- A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)
- A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
- A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)
- A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
- A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
- A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
- A Safety Study of Brentuximab Vedotin in Participants With HIV
- A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
- A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
- A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
- A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Approved for (5)
- Anaplastic large cell lymphoma
- Classic Hodgkin lymphoma
- Hodgkins lymphoma
- Neoplasm
- Non-Hodgkin lymphoma
In development for (24)
- Acute myeloid leukemia Phase 1
- Adult T-cell leukemia/lymphoma Phase 2
- B-cell chronic lymphocytic leukemia Phase 2
- Diffuse large B-cell lymphoma Phase 3
- Diffuse scleroderma Phase 2
- Enteropathy-associated T-cell lymphoma Phase 2
- Follicular lymphoma Phase 2
- Germ cell tumor Phase 2
- Graft versus host disease Phase 2
- HIV infectious disease Phase 1
- Leukemia Phase 1
- Lymphatic system disorder Phase 2
- Lymphoid neoplasm Phase 1
- Lymphoma Phase 3
- Malignant mesothelioma Phase 2
- Mast cell leukemia Phase 2
- Mature T-cell and NK-cell non-Hodgkin lymphoma Phase 2
- Mycosis fungoides Phase 3
- Neoplasm of mature B-cells Phase 2
- Peripheral T-cell lymphoma, not otherwise specified Phase 2
Targets (16)
- TNFRSF8 Tumor necrosis factor receptor superfamily member 8 binding agent
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor