Adcetris

brentuximab vedotin

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This is a summary of the European public assessment report (EPAR) for Adcetris. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcetris.

What is Adcetris?

Adcetris is a medicine that contains the active substance brentuximab vedotin. It is available as a powder that is made up into a solution for infusion (drip into a vein).

What is Adcetris used for?

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

  • 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 the cancer has come back or has not responded to at least two previous therapies and when autologous stem-cell transplant or multi-agent chemotherapy (a combination of anticancer medicines) are not treatment options.

Adcetris is also used to treat 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.

Because the number of patients with HL and sALCL is low, the diseases are considered ‘rare’, and Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 January 2009.

The medicine can only be obtained with a prescription.

How is Adcetris used?

Adcetris should be given under the supervision of a doctor who has experience in the use of cancer treatments.

The recommended dose is 1.8 mg per kilogram body weight given by a 30-minute infusion into a vein every three weeks. Patients should be monitored during and after the infusion for certain side effects and they should have full blood counts checked before every dose of Adcetris. Treatment should continue unless the disease gets worse or severe side effects develop. Patients who improve or whose disease stabilises may receive treatment for up to one year.

The doctor may decide to interrupt or stop treatment if the patient develops certain serious side effects. See the summary of product characteristics (also part of the EPAR) for more information.

How does Adcetris work?

The active substance in Adcetris, brentuximab vedotin, is made up of a CD30 monoclonal antibody (a type of protein that attaches to CD30). The monoclonal antibody is attached to monomethyl auristatin E, a cytotoxic (cell-killing) molecule. The monoclonal antibody delivers monomethyl auristatin E to the CD30-positive cancer cells, and once inside the cancer cells, it stops them from dividing, which eventually kills the cancer cells.

How has Adcetris been studied?

The effects of Adcetris were first tested in experimental models before being studied in humans.

In Hodgkin lymphoma, Adcetris has been studied in one main study in 102 patients with CD30-positive HL, who had previously received an autologous stem cell transplant and whose cancer had come back or had not responded to previous treatment. In addition, the company provided data on 40 patients with CD30-positive HL, whose cancer had come back or had not responded to at least two prior therapies and who are not eligible for autologous stem cell transplant or multi-agent chemotherapy.

In sALCL, Adcetris has been studied in one main study in 58 sALCL patients whose cancer had come back or had not responded to treatment.

In both studies the main measure of effectiveness was the percentage of patients who responded completely or partially to treatment. Response to treatment was assessed using body scans and  patients’ clinical data. A complete response is when a patient has no signs of the cancer.

What benefit has Adcetris shown during the studies?

In the study in HL, 75% of patients (76 out of 102) responded partially or completely to treatment. A complete response was observed in 33% of patients (34 out of 102). The data on the 40 patients showed that 55% of patients (22 out of 40) responded to treatment. For 23% of these patients (9 out of 40) a complete response was observed.

In the sALCL study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% of them (34 out of 58).

What is the risk associated with Adcetris?

Serious side effects reported with Adcetris include neutropenia (low white-blood-cell counts), thrombocytopenia (low blood platelet counts), constipation, diarrhoea, vomiting, pyrexia (fever), peripheral motor neuropathy (damage to the nerves causing difficulty coordinating movements) and peripheral sensory neuropathy (nerve damage in the hands and feet), hyperglycaemia (high blood glucose levels), demyelinating polyneuropathy (a neurological disorder characterised by slowly progressive weakness and a loss of sensation in the legs and arms), tumour-lysis syndrome (a potentially fatal complication due to the breakdown of cancer cells) and Stevens-Johnson syndrome (a life-threatening type of allergic reaction affecting the skin and mucous membranes). The most frequently observed side effects include peripheral sensory neuropathy, fatigue, nausea (feeling sick), diarrhoea, neutropenia, vomiting, pyrexia and infections. For the full list of all side effects reported with Adcetris, see the package leaflet.

Adcetris must not be used in people who are hypersensitive (allergic) to brentuximab vedotin or any of the other ingredients. It must not be used together with bleomycin (another anticancer medicine) as this combination is toxic to the lungs.

Why has Adcetris been approved?

The CHMP noted that, despite the fact that there were limited data and the studies did not compare Adcetris with a control treatment, Adcetris was considered beneficial for patients with HL and sALCL whose cancer had come back or had not responded to therapy. In these patients, who generally have poor outcomes and lack suitable treatments, Adcetris could lead to a complete response or could enable them to undergo potentially curative treatments. The Committee further noted that the overall safety profile of Adcetris was acceptable for these patients. Therefore, the CHMP decided that Adcetris’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Adcetris has been given ‘conditional approval’. This means that there is more evidence to come about, especially about the medicine’s long-term effects, such as duration of response and survival, which are needed to confirm the positive benefit-risk balance. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Adcetris?

The company that markets the medicine will provide follow-up data on patients’ survival from the main studies submitted in HL and sALCL. In addition, the company will carry out two further studies on the benefits of the medicine and a safety study in a larger population of HL and sALCL patients.

Other information about Adcetris

The European Commission granted a marketing authorisation valid throughout the European Union for Adcetris on 25 October 2012.

For more information about treatment with Adcetris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Adcetris : EPAR - Summary for the public BG = bălgarski 22/11/2012  
Adcetris : EPAR - Summary for the public ES = español 22/11/2012  
Adcetris : EPAR - Summary for the public CS = čeština 22/11/2012  
Adcetris : EPAR - Summary for the public DA = dansk 22/11/2012  
Adcetris : EPAR - Summary for the public DE = Deutsch 22/11/2012  
Adcetris : EPAR - Summary for the public ET = eesti keel 22/11/2012  
Adcetris : EPAR - Summary for the public EL = elliniká 22/11/2012  
Adcetris : EPAR - Summary for the public EN = English 22/11/2012  
Adcetris : EPAR - Summary for the public FR = français 22/11/2012  
Adcetris : EPAR - Summary for the public IT = italiano 22/11/2012  
Adcetris : EPAR - Summary for the public LV = latviešu valoda 22/11/2012  
Adcetris : EPAR - Summary for the public LT = lietuvių kalba 22/11/2012  
Adcetris : EPAR - Summary for the public HU = magyar 22/11/2012  
Adcetris : EPAR - Summary for the public MT = Malti 22/11/2012  
Adcetris : EPAR - Summary for the public NL = Nederlands 22/11/2012  
Adcetris : EPAR - Summary for the public PL = polski 22/11/2012  
Adcetris : EPAR - Summary for the public PT = português 22/11/2012  
Adcetris : EPAR - Summary for the public RO = română 22/11/2012  
Adcetris : EPAR - Summary for the public SK = slovenčina 22/11/2012  
Adcetris : EPAR - Summary for the public SL = slovenščina 22/11/2012  
Adcetris : EPAR - Summary for the public FI = suomi 22/11/2012  
Adcetris : EPAR - Summary for the public SV = svenska 22/11/2012  

This EPAR was last updated on 26/06/2014 .

Authorisation details

Product details

Product details for Adcetris
NameAdcetris
Agency product numberEMEA/H/C/002455
Active substance

brentuximab vedotin

International non-proprietary name (INN) or common name

brentuximab vedotin

Therapeutic area Hodgkin DiseaseLymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code L01XC12
Additional monitoring

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

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Adcetris
Marketing-authorisation holder

Takeda Pharma A/S

Revision6
Date of issue of marketing authorisation valid throughout the European Union25/10/2012

Contact address:

akeda Pharma A/S
Langebjerg 1
4000 Roskilde
Denmark

Product information

Product information

20/03/2014  Adcetris -EMEA/H/C/002455 -II/10

Name Language First published Last updated
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014
Adcetris : EPAR - Product Information SV = svenska 22/11/2012 26/06/2014

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.


Name Language First published Last updated
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  
Adcetris : EPAR - All Authorised presentations SV = svenska 22/11/2012  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

  1. following autologous stem-cell transplant (ASCT) or;
  2. 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 relapsed or refractory systemic anaplastic large-cell lymphoma (sALCL).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Adcetris : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 05/04/2013 26/06/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Adcetris : EPAR - Public assessment report SV = svenska 22/11/2012  
CHMP summary of positive opinion for Adcetris SV = svenska 20/07/2012  

Authorised

This medicine is approved for use in the European Union