MabThera

rituximab

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This is a summary of the European public assessment report (EPAR) for MabThera. 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 MabThera.

What is MabThera and what is it used for?

MabThera is a medicine used to treat the following blood cancers and inflammatory conditions:

  • follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer)
  • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells)
  • severe rheumatoid arthritis (an inflammatory condition of the joints)
  • two inflammatory conditions of blood vessels known as granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA).

Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid. MabThera contains the active substance rituximab.

How is MabThera used?

MabThera is given as an infusion (drip) into a vein. Patients with blood cancers can switch to an injection given under the skin after they have received one full dose of the infusion.

Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever). In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in an environment where facilities for resuscitating patients are immediately available.

MabThera is available as a concentrate that is made up into the solution for infusion and as a ready-made solution for the injection under the skin. It can only be obtained with a prescription.

How does MabThera work?

The active substance in MabThera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called CD20 present on the surface of B‑lymphocytes. When rituximab attaches to CD20, it causes the death of B‑lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B‑lymphocytes are involved in joint inflammation). In GPA and MPA, destroying the B-lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

What benefits of MabThera have been shown in studies?

Studies show:

MabThera to be effective in treating all the conditions for which it is approved. Some results from the main studies on the benefits of MabThera are described below:

  • In a follicular lymphoma study involving 322 patients, patients receiving MabThera in addition to chemotherapy lived for an average of 25.9 months without the disease coming back, compared with 6.7 months in those receiving chemotherapy alone.
  • In a studies of MabThera given on its own (203 patients), 48% of the patients with follicular lymphoma who had failed previous treatment responded to MabThera.
  • In a maintenance study in patients whose follicular lymphoma had come back after previous treatment, patients who received MabThera alone lived for an average of 42.2 months without the disease getting worse, compared with 14.3 months in patients who did not receive the medicine. A maintenance study in previously untreated patients showed the likelihood for the disease to get worse was reduced by 50% for patients who received MabThera.
  • In a study of 399 patients with diffuse large B-cell lymphoma, patients adding MabThera to chemotherapy lived for an average of 35 months without the disease getting worse or the need for a change in treatment, compared with 13 months in those receiving chemotherapy alone.
  • In a study of 817 patients with CLL, patients who had not been treated before lived for an average of 39.8 months without their disease getting worse when they received MabThera in addition to chemotherapy, compared with 32.2 months in patients receiving chemotherapy alone. In patients whose disease had come back after previous treatment, those receiving MabThera lived for 30.6 months without their disease getting worse, compared with 20.6 months in those receiving chemotherapy alone.
  • In a study of 517 patients with rheumatoid arthritis, MabThera was more effective than placebo: 51% of the patients receiving MabThera had an improvement in symptoms, compared with 18% of the patients receiving placebo.
  • In a study of 198 patients with GPA or MPA, 64% of patients given MabThera were in complete remission after six months, compared with 55% given cyclophosphamide, a comparator medicine.
What is the risk associated with MabThera?

The most common side effects with Mabthera intravenous infusions are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heart-related problems. Similar side effects are seen when Mabthera is injected under the skin, with the exception of reactions around the injections site (pain, swelling and rash), which occur more frequently with the skin injections. For the full list of side effects reported with MabThera, see the package leaflet.

MabThera must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system. The formulation injected under the skin must also not be used in patients who are allergic to a substance called hyaluronidase.

Patients with rheumatoid arthritis, GPA or MPA must not receive MabThera if they have severe heart problems.

Why has MabThera been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that MabThera’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

The company marketing MabThera will provide doctors and patients using the medicine for rheumatoid arthritis with educational material on the risk of infection including of a rare severe infection known as progressive multifocal leukoencephalopathy (PML). These patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they experience symptoms of infection.

All doctors administering MabThera under the skin will also receive educational material to minimise the risk of improper use or errors.

In addition, the company that markets MabThera will also submit reports from studies on the long-term safety of MabThera.

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

Other information about MabThera

The European Commission granted a marketing authorisation valid throughout the European Union for MabThera on 2 June 1998.

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

Name Language First published Last updated
MabThera : EPAR - Summary for the public (English only) 30/10/2009 17/06/2016

This EPAR was last updated on 17/06/2016 .

Authorisation details

Product details

Product details for MabThera
NameMabThera
Agency product numberEMEA/H/C/000165
Active substance

rituximab

International non-proprietary name (INN) or common name

rituximab

Therapeutic area Arthritis, RheumatoidLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XC02

Publication details

Publication details for MabThera
Marketing-authorisation holder

Roche Registration Ltd

Revision37
Date of issue of marketing authorisation valid throughout the European Union02/06/1998

Contact address:

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

Product information

26/05/2016  MabThera -EMEA/H/C/000165 -X/0101/G

Name Language First published Last updated
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016
MabThera : EPAR - Product Information EN = English 30/10/2009 10/06/2016

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
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016
MabThera : EPAR - All Authorised presentations EN = English 29/09/2006 10/06/2016

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

MabThera is indicated in adults for the following indications:

Non-Hodgkin's lymphoma

MabThera is indicated for the treatment of previously untreated patients with stage-III-IV follicular lymphoma in combination with chemotherapy.

MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

MabThera monotherapy is indicated for treatment of patients with stage-III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.

MabThera is indicated for the treatment of patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

Chronic lymphocytic leukaemia

MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed / refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.

Rheumatoid arthritis

MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying antirheumatic drugs (DMARDs) including one or more tumour-necrosis-factor (TNF)-inhibitor therapies.

MabThera has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
MabThera : EPAR - Procedural steps taken and scientific information after authorisation EN = English 30/10/2009 10/06/2016
MabThera-H-C-165-X-101-G: EPAR - Assessment Report - Variation EN = English 10/06/2016  
MabThera-H-C-165-X-83 : EPAR - Assessment Report - Extension EN = English 06/06/2014  
MabThera-H-C-165-II-79 : EPAR - Assessment Report - Variation EN = English 24/09/2013  
MabThera-H-C-165-A20-78 : EPAR - Assessment Report - Article 20 EN = English 15/08/2013  
CHMP post-authorisation summary of positive opinion for MabThera EN = English 22/03/2013  
MabThera-H-C-165-II-65: EPAR - Assessment Report - Variation EN = English 01/12/2010  
MabThera-H-C-165-II-69 : EPAR - Assessment Report - Variation EN = English 01/12/2010  
CHMP post-authorisation summary of positive opinion for MabThera EN = English 24/09/2010  
MabThera-H-C-259-II-64 : EPAR - Assessment Report - Variation EN = English 30/10/2009  
CHMP post-authorisation summary of positive opinion for Mabthera on 23 July 2009 EN = English 23/07/2009  
MabThera-H-C-259-II-60 : EPAR - Assessment Report - Variation EN = English 08/04/2009  
CHMP post-authorisation summary of positive opinion for Mabthera on 22 January 2009 EN = English 23/01/2009  
MabThera-H-C-259-II-53 : EPAR - Assessment Report - Variation EN = English 10/06/2008  
Committee for medicinal products for human use, post-authorisation summary of positive opinion for Mabthera on 13 December 2007 EN = English 20/12/2007  
MabThera-H-C-259-II-44 : EPAR - Assessment Report - Variation EN = English 29/09/2006  
MabThera-H-C-259-II-39 : EPAR - Assessment Report - Variation EN = English 29/09/2006  
MabThera : EPAR - Steps taken after authorisation when a cutoff date has been used EN = English 29/09/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
MabThera : EPAR - Procedural steps taken before authorisation EN = English 29/09/2006  
MabThera : EPAR - Scientific Discussion EN = English 29/09/2006  

Authorised

This medicine is approved for use in the European Union

More information on MabThera