Adcetris is a cancer medicine used to treat adults with certain lymphomas (cancers of lymphocytes, white blood cells that are part of the immune system). It is used when the cancer cells have a protein called CD30 on their surface (CD30-positive).
For Hodgkin’s lymphoma (HL), it is given:
- together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in patients who have stage IV disease (advanced cancer that has spread outside the lymphatic system) that has not been treated before;
- when the cancer has come back or has not responded to an autologous stem cell transplant (a transplant of the patient's own blood-producing cells);
- if the cancer is likely to come back or get worse after an autologous stem cell transplant;
- when the cancer has come back or has not responded to at least two other therapies and when autologous stem cell transplant or multi-agent chemotherapy (a combination of cancer medicines) cannot be used;
In non-Hodgkin’s lymphoma, Adcetris is used for:
- systemic anaplastic large cell lymphoma (sALCL, a cancer of lymphocytes called T-cells) when the cancer has never been treated before; Adcetris is used together with cyclophosphamide, doxorubicin and prednisone. It is also used when the cancer has come back or when other treatments have not worked;
- cutaneous T-cell lymphoma (CTCL), a lymphoma of T-cells that initially affects the skin, in patients who have received at least one previous treatment.
These diseases are rare, and Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases).
Adcetris contains the active substance brentuximab vedotin.
Adcetris : EPAR - Medicine overview (PDF/184.83 KB)
First published: 22/11/2012
Last updated: 08/06/2020
Adcentris : EPAR - Risk-management-plan summary (PDF/77.84 KB)
First published: 13/03/2019
Last updated: 08/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Takeda Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
12/05/2020 Adcetris - EMEA/H/C/002455 - II/0070
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Adcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1).
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) (see section 5.1).
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 lymphoma
Adcetris 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 lymphoma
Adcetris is indicated for the treatment of adult patients with CD30+ cutaneous T cell lymphoma (CTCL) after at least 1 prior systemic therapy.