Adcetris (brentuximab vedotin) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Takeda Pharma A/S. Adcetris (brentuximab vedotin) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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). 1
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). 1
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): (i) following ASCT, or (ii) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. 1
ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. 1
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). 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
EMA (1) CD30 + Hodgkin Lymphoma Brentuximab vedotin, Dacarbazine, Doxorubicin, Vinblastine
EMA (2) CD30 + Hodgkin Lymphoma Brentuximab vedotin
EMA (1) CD30 + Cutaneous T-cell Lymphoma Brentuximab vedotin
EMA (1) CD30 + Hodgkin Lymphoma Brentuximab vedotin, Cyclophosphamide, Dacarbazine, Dexamethasone, Doxorubicin, Etoposide