Imbruvica

ibrutinib

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This is a summary of the European public assessment report (EPAR) for Imbruvica. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Imbruvica.

For practical information about using Imbruvica, patients should read the package leaflet or contact their doctor or pharmacist.

What is Imbruvica and what is it used for?

Imbruvica is a cancer medicine that is used to treat the following types of blood cancer that affect a type of white blood cells called B lymphocytes:

  • chronic lymphocytic leukaemia. Imbruvica is used in previously untreated adults as well as in adults who have received previous treatment;
  • mantle cell lymphoma. Imbruvica is used in adults whose disease does not respond to or has come back after previous treatment;
  • Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma). Imbruvica is used in adults who have received previous treatment for their disease, or in previously untreated patients for whom treatment with chemo-immunotherapy is not suitable.

Because the number of patients with these cancers is low, they are considered ‘rare’, and Imbruvica was designated an ‘orphan medicine’ (a medicine used in rare diseases).

Imbruvica contains the active substance ibrutinib.

How is Imbruvica used?

Imbruvica can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in using cancer medicines.

Imbruvica is available as 140 mg capsules. In chronic lymphocytic leukaemia and Waldenström’s macroglobulinaemia, the recommended dose is 3 capsules once a day, whereas in mantle cell lymphoma it is 4 capsules once a day. Treatment should be taken at the same time each day and should be continued for as long as the disease improves or remains stable and the side effects are tolerable. If the patient is taking certain other medicines that may interact with Imbruvica or experiences severe side effects, the dose may be lowered or treatment interrupted as needed. A dose reduction is recommended in patients with mildly or moderately reduced liver function, whereas Imbruvica is not recommended in patients with severely reduced liver function. For more information, see the summary of product characteristics (also part of the EPAR).

How does Imbruvica work?

The active substance in Imbruvica, ibrutinib, works by blocking an enzyme called Bruton’s tyrosine kinase (Btk), which is mostly found in B lymphocytes. Btk promotes survival of B lymphocytes and their migration to the organs where these cells normally divide. By blocking Btk, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying the progression of the cancer.

What benefits of Imbruvica have been shown in studies?

Imbruvica has been studied in 2 main studies in patients with chronic lymphocytic leukaemia. In the first study, involving 391 patients whose disease did not respond to or had come back after previous treatment, Imbruvica was shown to be more effective than ofatumumab (another cancer medicine) at delaying progression of the cancer. After 1 year of treatment, around 66% of patients receiving Imbruvica were still alive with their disease not having progressed compared with around 6% of patients receiving ofatumumab. In the second study, involving 269 patients who had not been treated before, Imbruvica was shown to be more effective than the cancer medicine chlorambucil at delaying progression of the cancer. After 1.5 years of treatment, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed compared with around 52% of patients receiving chlorambucil.

Imbruvica was also investigated in a main study involving 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment. In this study Imbruvica was not compared with any other treatment. Results of the study showed Imbruvica to be effective, with around 68% of patients having either a complete or partial response to treatment: 21% of patients had a complete response (i.e. disappearance of all signs of cancer following treatment) and 47% had a partial response (i.e. the patient improved but some signs of the disease remained). The average duration of response to treatment was 17.5 months.

In Waldenström’s macroglobulinaemia, Imbruvica was studied in one main study involving 63 patients who had previously received another treatment for their disease. Imbruvica was not compared with any other treatment in this study. The study showed that around 87% (55 out of 63) of patients responded to treatment with Imbruvica. Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström’s disease.

What are the risks associated with Imbruvica?

The most common side effects with Imbruvica (which may affect more than 1 in 5 people) are diarrhoea, musculoskeletal pain (pain in muscles and bones), upper respiratory tract infections (such as colds), haemorrhage (bleeding), bruising, rash and nausea (feeling sick). The most serious side effects are anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), pneumonia (lung infection) and thrombocytopenia (low blood platelet counts). For the full list of all side effects reported with Imbruvica, see the package leaflet.

St. John’s wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica. For the full list of restrictions, see the package leaflet.

Why is Imbruvica approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Imbruvica’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in patients who had received previous treatment and those previously untreated. The Committee noted that Imbruvica was also effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group with poor prognosis and few other treatment options. Regarding Waldenström’s macroglobulinaemia, Imbruvica had also a clinically relevant effect in previously treated patients, and the CHMP considered that the medicine could also benefit previously untreated patients who are unsuitable for chemo-immunotherapy and for whom no satisfactory treatments are available. In addition, the safety of the medicine was considered acceptable.

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

The company will provide further data on the benefits of Imbruvica in the treatment of mantle cell lymphoma from a study comparing the medicine with temsirolimus (another cancer medicine) and further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-ups of patients in the study in previously treated patients.

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

Other information about Imbruvica

The European Commission granted a marketing authorisation valid throughout the European Union for Imbruvica on 21 October 2014.

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

Name Language First published Last updated
Imbruvica : EPAR - Summary for the public BG = bălgarski 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public ES = español 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public CS = čeština 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public DA = dansk 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public DE = Deutsch 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public ET = eesti keel 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public EL = elliniká 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public EN = English 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public FR = français 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public IT = italiano 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public LV = latviešu valoda 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public LT = lietuvių kalba 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public HU = magyar 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public MT = Malti 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public NL = Nederlands 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public PL = polski 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public PT = português 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public RO = română 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public SK = slovenčina 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public SL = slovenščina 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public FI = suomi 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public SV = svenska 25/11/2014 27/07/2016
Imbruvica : EPAR - Summary for the public HR = Hrvatski 25/11/2014 27/07/2016
Name Language First published Last updated
Imbruvica : EPAR - Risk-management-plan summary (English only) 25/11/2014  

This EPAR was last updated on 09/06/2016 .

Authorisation details

Product details

Product details for Imbruvica
NameImbruvica
Agency product numberEMEA/H/C/003791
Active substance

ibrutinib

International non-proprietary name (INN) or common name

ibrutinib

Therapeutic area Lymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XE27
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.

Publication details

Publication details for Imbruvica
Marketing-authorisation holder

Janssen-Cilag International NV

Revision6
Date of issue of marketing authorisation valid throughout the European Union21/10/2014

Contact address:

Janssen-Cilag International NV
Turnhoutseweg 30 
2340 Beerse 
Belgium

Product information

Product information

27/07/2016  Imbruvica -EMEA/H/C/003791 -II/0016

Name Language First published Last updated
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016
Imbruvica : EPAR - Product Information EN = English 25/11/2014 09/06/2016

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
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  
Imbruvica : EPAR - All Authorised presentations EN = English 25/11/2014  

Pharmacotherapeutic group

Antineoplastic agents, protein kinase inhibitors

Therapeutic indication

Imbruvica is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Imbruvica as a single agent is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).

Imbruvica is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

Imbruvica is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Imbruvica : EPAR - Public assessment report EN = English 25/11/2014  
CHMP summary of positive opinion for Imbruvica EN = English 25/07/2014