Adcetris

RSS

brentuximab vedotin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 14/10/2020

Authorisation details

Product details
Name
Adcetris
Agency product number
EMEA/H/C/002455
Active substance
Brentuximab vedotin
International non-proprietary name (INN) or common name
brentuximab vedotin
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
Anatomical therapeutic chemical (ATC) code
L01XC12
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
25/10/2012
Contact address

Delta Park 45
2665 Vallensbaek Strand
Denmark

Product information

25/09/2020 Adcetris - EMEA/H/C/002455 - IB/0081

Contents

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Hodgkin lymphoma

Adcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

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).

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.


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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating