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 December 2023. Accessed March 11, 2024.

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

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD30 +	Hodgkin Lymphoma	Brentuximab Vedotin, Dacarbazine, Doxorubicin, Vinblastine
Sensitivity (+)	CD30 +	Hodgkin Lymphoma	Brentuximab Vedotin
Sensitivity (+)	CD30 +	Hodgkin Lymphoma	Brentuximab Vedotin
Sensitivity (+)	CD30 +	Cutaneous T-cell Lymphoma	Brentuximab Vedotin