Arzerra

ofatumumab

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

What is Arzerra?

Arzerra is a cancer medicine that contains the active substance ofatumumab. It is available as a concentrate that is made up into a solution for infusion (drip into a vein).

What is Arzerra used for?

Arzerra is used to treat chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes. It is used together with chlorambucil or bendamustine (other cancer medicines) in previously untreated patients who cannot be treated with therapy based on another cancer medicine, fludarabine. It can also be used in patients whose disease has not responded to previous treatment with fludarabine and a medicine called alemtuzumab.

Because the number of patients with CLL is low, the disease is considered ‘rare’, and Arzerra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 7 November 2008.

The medicine can only be obtained with a prescription.

How is Arzerra used?

Arzerra should be given under the supervision of a doctor who has experience in treating cancer and in a place where facilities for resuscitating patients are readily available.

Arzerra is given using an infusion pump. In previously untreated patients, the first Arzerra infusion should contain 300 mg on day 1, followed 7 days later by 1,000 mg. All subsequent infusions (which should be between 2 and 11 more infusions) should contain 1,000 mg given once a month.

In patients who did not respond to previous treatment, the first Arzerra infusion should contain 300 mg, and the following 7 infusions should contain 2,000 mg given once a week. This is followed by a gap of four to five weeks, after which the patient is given an infusion of 2,000 mg once a month for four months.

Before each infusion, the patient is treated with medicines, such as corticosteroids, antihistamines and paracetamol, to help to prevent infusion reactions (such as rash, fever, allergic reactions and difficulty breathing). To reduce the risk of these reactions, infusions are started slowly (particularly when first starting treatment) and then speeded up every 30 minutes if no reactions occur. If reactions do occur, treatment should be interrupted and restarted at a slower rate when the patient has recovered. For more information on how to use Arzerra, see the summary of product characteristics (also part of the EPAR).

How does Arzerra work?

The active substance in Arzerra, ofatumumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body. Ofatumumab has been designed to attach to a protein called CD20 that is found on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL. By attaching to CD20, ofatumumab stimulates the body’s immune system to attack the cancerous cells, helping to control the disease.

How has Arzerra been studied?

Arzerra has been investigated in one main study involving 223 patients with CLL whose disease had not responded to previous treatment. In 95 of these patients, the disease had not responded to both fludarabine and alemtuzumab, and in 112, treatment with fludarabine had failed but they had not been treated with alemtuzumab because this medicine was not suitable for them. The remaining 16 patients did not fall into either group. Arzerra was not compared with any other treatments in this study. The main measure of effectiveness was the number of patients who ‘responded’ to treatment. The response to treatment was assessed by looking at the patients’ symptoms, the number of lymphocytes in their blood, results of blood and bone marrow tests and the size of their lymph nodes, liver and spleen.

Arzerra has also been studied in one main study involving 447 previously untreated patients who could not be treated with fludarabine-based therapy. Arzerra given together with chlorambucil was compared with chlorambucil alone. The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).

What benefit has Arzerra shown during the studies?

In the study in patients whose disease had not responded to previous treatment, 49% of the patients whose previous treatment with both fludarabine and alemtuzumab had failed (47 out of 95) responded to treatment with Arzerra. The response rate was slightly lower in patients whose treatment with fludarabine had failed but who were not suitable for treatment with alemtuzumab (43%).

In previously untreated patients, Arzerra plus chlorambucil was effective at increasing progression-free survival, with patients living on average for 22.4 months without their disease getting worse, compared with 13.1 in patients given chlorambucil alone.

What is the risk associated with Arzerra?

The most common side effects with Arzerra (seen in more than 1 patient in 10) are lower respiratory tract infection (infection of the lungs such as pneumonia), upper respiratory tract infection (colds), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), nausea (feeling sick), pyrexia (fever) and rash. Arzerra treatment can also lead to infusion reactions, especially during the first infusion, which is why facilities for resuscitating patients should be readily available.

For the full list of all side effects and restrictions with Arzerra, see the package leaflet.

Why has Arzerra been approved?

The Committee decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation. The CHMP noted that Arzerra was shown to be effective at treating patients with CLL (both previously untreated patients and patients who had not responded to previous treatment with fludarabine and alemtuzumab). The Committee also noted that patients with CLL who had not responded to previous treatment have limited treatment options.

Arzerra has been given ‘conditional approval’. This means that there is more evidence to come about the medicine. 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 Arzerra?

The company that makes Arzerra will carry out a study comparing treatment with Arzerra to treatment with other cancer medicines chosen by the doctor, in patients with CLL whose previous treatment with fludarabine has failed.

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

A risk management plan has been developed to ensure that Arzerra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arzerra, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company will also provide additional information on the effectiveness and safety of Arzerra collected once it is being used in patients after marketing. The company will investigate ways that may help to identify patients suitable for Arzerra treatment.

Other information about Arzerra

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Arzerra on 19 April 2010.

For more information about treatment with Arzerra, read the package leaflet (also part of the EPAR).

Name Language First published Last updated
Arzerra : EPAR - Summary for the public BG = bălgarski 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public ES = español 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public CS = čeština 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public DA = dansk 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public DE = Deutsch 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public ET = eesti keel 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public EL = elliniká 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public EN = English 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public FR = français 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public IT = italiano 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public LV = latviešu valoda 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public LT = lietuvių kalba 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public HU = magyar 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public MT = Malti 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public NL = Nederlands 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public PL = polski 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public PT = português 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public RO = română 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public SK = slovenčina 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public SL = slovenščina 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public FI = suomi 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public SV = svenska 14/06/2010 05/08/2014
Arzerra : EPAR - Summary for the public HR = Hrvatski 14/06/2010 05/08/2014

This EPAR was last updated on 05/12/2014 .

Authorisation details

Product details

Product details for Arzerra
NameArzerra
Agency product numberEMEA/H/C/001131
Active substance

ofatumumab

International non-proprietary name (INN) or common name

ofatumumab

Therapeutic area Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XC10
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 Arzerra
Marketing-authorisation holder

Glaxo Group Ltd

Revision8
Date of issue of marketing authorisation valid throughout the European Union19/04/2010

Contact address:

Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Product information

Product information

30/10/2014  Arzerra -EMEA/H/C/001131 -IB/0032

Name Language First published Last updated
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014
Arzerra : EPAR - Product Information HR = Hrvatski 14/06/2010 05/12/2014

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
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014
Arzerra : EPAR - All Authorised presentations HR = Hrvatski 14/06/2010 05/08/2014

Pharmacotherapeutic group

Monoclonal antibodies

Therapeutic indication

Treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Arzerra : EPAR - Public assessment report HR = Hrvatski 14/06/2010  
CHMP summary of positive opinion for Arzerra HR = Hrvatski 22/01/2010  

Authorised

This medicine is approved for use in the European Union

Related information

More information on Arzerra