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 and what is it used for?

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) 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 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.

Because the number of patients with these conditions is low, the diseases are considered ‘rare’, and Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates (see below).

Adcetris contains the active substance brentuximab vedotin.

How is Adcetris used?

Adcetris can only be obtained with a prescription, and it 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 (drip) 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 (tests of the number of blood cells) before every dose of Adcetris. Treatment should continue for up to 1 year (16 cycles of treatment) unless the disease gets worse or severe side effects develop.

The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects. For further information, see the package leaflet.

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, and the cancer cells eventually die.

How has Adcetris been studied?

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

In HL, 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. Adcetris was also compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back.

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 the first HL study, and in the sALCL study, both involving patients whose disease had already come back or not responded, 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. In the second HL study (in patients with HL at increased risk of progressing or coming back), the main measure of effectiveness was how long patients lived without their disease getting worse.

What benefit has Adcetris shown during the studies?

Hodgkin’s lymphoma

In a main study, Adcetris was used 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. 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 cancer.In this study, 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).

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 were not eligible for autologous stem cell transplant or multi-agent chemotherapy. The data on these 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 another main study, Adcetris was compared with placebo (a dummy treatment) in 329 patients with CD30-positive HL who had received an autologous stem cell transplant and who were at increased risk of their cancer progressing or coming back. The main measure of effectiveness was how long patients lived without their disease getting worse. In this study, the average time patients lived before their disease got worse was around 43 months in those given Adcetris, compared with around 24 months in those given placebo. The benefit was sustained during 3 years of follow-up.

Systemic anaplastic large cell lymphoma

Adcetris was studied in 58 sALCL patients whose cancer had come back or had not responded to treatment. 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 cancer. In this study, 86% of patients (50 out of 58) responded partially or completely to treatment and this response was complete for 59% (34 out of 58).

Cutaneous T-cell lymphoma

Adcetris has been shown to be of benefit in CD30-positive cutaneous T-cell lymphoma in a main study in 128 patients with CD30-positive CTCL who had had at least one previous treatment. The study compared treatment with Adcetris and treatment with another appropriate medicine (methotrexate or bexarotene). The proportion of patients whose disease responded to treatment for at least 4 months was 56% of those given Adcetris (36 of 64 patients) and 13% of those given alternative treatments (8 of 64 patients).

What are the risks associated with Adcetris?

The most frequent side effects (which may affect more than 1 in 10 people) are infections (including infections of the nose and throat) peripheral sensory or motor neuropathy (nerve damage that affects feeling or muscle control and co-ordination), tiredness, nausea (feeling sick), diarrhoea, fever, neutropenia (low white blood cell count), rash, cough, vomiting, joint pain, infusion-related reactions, itching, constipation, dyspnoea (difficulty breathing), weight loss, muscle pain and abdominal (belly) pain.

Adcetris must not be used together with bleomycin (another cancer medicine) as this combination is damaging to the lungs. For the full list of all side effects and restrictions with Adcetris, see the package leaflet.

Why has Adcetris been approved?

The European Medicines Agency noted that, despite limited data and studies that 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 cure or could enable them to undergo potentially curative treatments. In addition, giving Adcetris to patients who have had a stem cell transplant and are considered at risk of the cancer progressing or coming back, resulted in a clear clinical benefit. In patients with CTCL a clinically significant benefit was seen over treatment with bexarotene or methotrexate. The Agency further noted that the overall safety profile of Adcetris was acceptable given the serious conditions for which it is used. Therefore, the Agency decided that Adcetris’ benefits are greater than its risks and recommended that it be approved for use in the EU.

Adcetris has been given ‘conditional approval’. This means that there is more evidence to come, especially about the medicine’s long-term effects, which are needed to confirm the positive benefit-risk balance. Every year, the 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.

What measures are being taken to ensure the safe and effective use of Adcetris?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adcetris have been included in the summary of product characteristics and the package leaflet.

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 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public ES = español 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public CS = čeština 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public DA = dansk 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public DE = Deutsch 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public ET = eesti keel 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public EL = elliniká 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public EN = English 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public FR = français 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public IT = italiano 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public LV = latviešu valoda 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public LT = lietuvių kalba 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public HU = magyar 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public MT = Malti 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public NL = Nederlands 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public PL = polski 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public PT = português 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public RO = română 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public SK = slovenčina 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public SL = slovenščina 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public FI = suomi 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public SV = svenska 2012-11-22 2018-02-01
Adcetris : EPAR - Summary for the public HR = Hrvatski 2012-11-22 2018-02-01

This EPAR was last updated on 01/02/2018 .

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

Revision21
Date of issue of marketing authorisation valid throughout the European Union25/10/2012

Contact address:

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

Product information

15/12/2017  Adcetris -EMEA/H/C/002455 -II/0048

Name Language First published Last updated
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01
Adcetris : EPAR - Product Information HR = Hrvatski 2012-11-22 2018-02-01

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 HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  
Adcetris : EPAR - All Authorised presentations HR = Hrvatski 2012-11-22  

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

Initial marketing-authorisation documents

Name Language First published Last updated
Adcetris : Orphan maintenance assessment report HR = Hrvatski 2018-02-01  
Adcetris : EPAR - Public assessment report HR = Hrvatski 2012-11-22  
CHMP summary of positive opinion for Adcetris HR = Hrvatski 2012-07-20