Adcetris

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brentuximab vedotin

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

Overview

Adcetris is a cancer medicine used to treat adults with Hodgkin’s lymphoma (HL, a type of cancer that originates from blood cells in the lymphatic system, a part of the immune system). Adcetris is used when the tumour cells are CD30-positive (when they have a protein called CD30 on their surface) and is given:

  • together with doxorubicin, vinblastine and dacarbazine (other cancer medicines) in HL patients who have stage IV disease (advanced cancer that has spread to other parts of the body) 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);

  • when patients have had an autologous stem cell transplant but are considered to be at increased risk of the cancer coming back or not responding;

  • 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.

    Adcetris is also used to treat adults with two other lymphomas:

  • systemic anaplastic large cell lymphoma (sALCL, a CD30-positive cancer of white blood cells called T lymphocytes), when the cancer has come back or has not responded to other treatments;

  • CD30-positive cutaneous T-cell lymphoma (CTCL), a lymphoma of T lymphocytes 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) on various dates. Further information on the orphan designations can be found on the European Medicines Agency’s website (Hodgkin’s lymphoma: 15 January 2009; Anaplastic large cell lymphoma: 15 January 2009; Cutaneous T-cell lymphoma: 11 January 2012).

    Adcetris contains the active substance brentuximab vedotin.

This EPAR was last updated on 13/03/2019

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
24
Date of issue of marketing authorisation valid throughout the European Union
25/10/2012
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

06/02/2019 Adcetris - EMEA/H/C/002455 - II/0055

Contents

  • 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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):

  • following autologous stem cell transplant (ASCT) or
  • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT.

Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Assessment history

Changes since initial authorisation of medicine

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