# Brentuximab vedotin

Brentuximab vedotin (Adcetris, Takeda Pharma A/S) has 7 EU-approved indications in 2 tumour types. 5 need a biomarker result: CD30 (5).

## Approved indications

### Hodgkin lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| CD30 CD30+ | + doxorubicin, vinblastine and dacarbazine | 1st line, advanced | - |
| CD30 CD30+ | + etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone | 1st line, advanced | Stage IIB with risk factors, Stage III or Stage IV |
| CD30 CD30+ | Monotherapy | Consolidation | Following autologous stem cell transplant (ASCT); At increased risk of relapse or progression Ambiguous in the label (treatment phase): check the SmPC. |
| CD30 CD30+ | Monotherapy | 3rd line+ | Following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option |

### T-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + cyclophosphamide, doxorubicin and prednisone | 1st line | Systemic ALCL only |
| None | Monotherapy | 2nd line | Systemic ALCL only; Relapsed or refractory disease |
| CD30 CD30+ | Monotherapy | 2nd line | Cutaneous T-cell lymphoma only; After at least 1 prior systemic therapy |

## Products

### Adcetris

- Company: Takeda Pharma A/S
- Target: CD30-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX05
- EU approval: 25 Oct 2012
- Label revised: 20 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/adcetris-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/adcetris

Mechanism (SmPC section 5.1): Binds CD30, internalises, and releases MMAE to disrupt the microtubule network via tubulin binding, leading to cell cycle arrest and apoptosis.

## Label wording

- **Brentuximab vedotin** (Adcetris), Hodgkin lymphoma, 1st line, advanced: “ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), Hodgkin lymphoma, 1st line, advanced: “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) (see sections 4.2 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), Hodgkin lymphoma, consolidation: “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) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), Hodgkin lymphoma, 3rd line+: “ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), T-cell lymphoma, 1st line: “ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), T-cell lymphoma, 2nd line: “ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)
- **Brentuximab vedotin** (Adcetris), T-cell lymphoma, 2nd line: “ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/brentuximab-vedotin