Atriance

nelarabine

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

What is Atriance?

Atriance is a solution for infusion. It contains the active substance nelarabine.

What is Atriance used for?

Atriance is used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly. In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland). Atriance is used when patients have failed to respond to, or have stopped responding to, at least two types of chemotherapy.

Because the number of patients with these diseases is low, the diseases are considered ‘rare’, and Atriance was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 June 2005.

The medicine can only be obtained with a prescription.

How is Atriance used?

Atriance is given by intravenous infusion (a drip into a vein) under the supervision of a doctor who has experience in the use of these types of medicine. The dose and frequency of infusion depend on the patient’s age and body surface area. In adults and adolescents aged over 16 years, the recommended starting dose is 1,500 mg per square metre, given over two hours on days one, three and five, repeated every 21 days. Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days. This schedule can also be used in patients aged 16 to 21 years. Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.

Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).

How does Atriance work?

The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells. It belongs to the group of anticancer medicines called ‘antimetabolites’.

Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA. In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases. This stops the production of DNA and thus slows down the growth and multiplication of cells. As the guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.

How has Atriance been studied?

Atriance has been studied in two main studies of patients with T-ALL and T-LBL who had stopped responding to one or more previous anticancer treatments. The first study involved a total of 70 children and young adults aged below 21 years, and the second involved a total of 40 adults and adolescents aged over 16 years. Around half of the patients had failed two or more previous treatments. In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine. The main measure of effectiveness was the proportion of patients who responded to treatment, defined as no evidence of disease and recovery of blood cell counts, within a month of starting Atriance treatment.

What benefit has Atriance shown during the studies?

Atriance was shown to be effective in a proportion of the patients in both studies. In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts. In the second study, among the 28 adults and adolescents who had failed two or more previous treatments, five (18%) had a complete response to treatment. In both studies, more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.

What is the risk associated with Atriance?

The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white-blood-cell counts with fever), neutropenia (low white-blood-cell counts), thrombocytopenia (low platelet counts), anaemia (low red-blood-cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness). Most of these side effects were also seen very commonly in children. For the full list of all side effects reported with Atriance, see the package leaflet.

Severe side effects affecting the brain and nervous system have been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis. Patients should be monitored closely for these side effects and treatment stopped if necessary.

Atriance must not be used in people who are hypersensitive (allergic) to nelarabine or any of the other ingredients.

Why has Atriance been approved?

The CHMP noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive a bone-marrow transplant, increasing their chances of survival. Therefore, the Committee decided that Atriance’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Atriance has been authorised under ‘exceptional circumstances’. This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance. 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 Atriance?

The company that makes Atriance will supply information from studies into the safety of Atriance in children and young adults, including one study of Atriance taken in combination with other anticancer medicines.

Other information about Atriance

The European Commission granted a marketing authorisation valid throughout the European Union for Atriance on 22 August 2007.

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

Name Language First published Last updated
Atriance : EPAR - Summary for the public BG = bălgarski 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public ES = español 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public CS = čeština 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public DA = dansk 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public DE = Deutsch 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public ET = eesti keel 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public EL = elliniká 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public EN = English 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public FR = français 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public IT = italiano 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public LV = latviešu valoda 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public LT = lietuvių kalba 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public HU = magyar 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public MT = Malti 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public NL = Nederlands 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public PL = polski 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public PT = português 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public RO = română 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public SK = slovenčina 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public SL = slovenščina 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public FI = suomi 20/09/2007 02/07/2012
Atriance : EPAR - Summary for the public SV = svenska 20/09/2007 02/07/2012

This EPAR was last updated on 18/02/2014 .

Authorisation details

Product details

Product details for Atriance
NameAtriance
Agency product numberEMEA/H/C/000752
Active substance

nelarabine

International non-proprietary name (INN) or common name

nelarabine

Therapeutic area Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01BB07
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.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Atriance
Marketing-authorisation holder

Glaxo Group Limited

Revision11
Date of issue of marketing authorisation valid throughout the European Union22/08/2007

Contact address:

Glaxo Group Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

Product information

Product information

20/12/2013  Atriance -EMEA/H/C/000752 -S/0021

Name Language First published Last updated
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014
Atriance : EPAR - Product Information SV = svenska 15/04/2009 18/02/2014

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
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  
Atriance : EPAR - All Authorised presentations SV = svenska 20/09/2007  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Due to the small patient populations in these disease settings, the information to support theseindications is based on limited data.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Atriance : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 16/04/2009 18/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Atriance : EPAR - Procedural steps taken before authorisation SV = svenska 20/09/2007  
Atriance : EPAR - Scientific Discussion SV = svenska 20/09/2007  

Authorised

This medicine is approved for use in the European Union

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