ADCETRIS
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for the treatment of various CD30-expressing malignancies, including classical Hodgkin lymphoma (cHL) and several types of T-cell and B-cell lymphomas. It is utilized in both adult and pediatric populations, serving as a first-line treatment in combination with chemotherapy or as a therapy for relapsed and refractory cases. The drug's therapeutic role also extends to post-transplantation consolidation and for patients who are ineligible for stem cell transplants or CAR T-cell therapy.
How ADCETRIS Works
ADCETRIS is an antibody-drug conjugate comprising a CD30
Details
- Status
- Prescription
- First Approved
- 2011-08-19
- 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 ).
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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
ProIndications & Usage
FDA Label (PDF)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 . • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide . • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell tran...
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.