Evoltra

clofarabine

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

What is Evoltra?

Evoltra is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance clofarabine.

What is Evoltra used for?

Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell). It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work.

Because the number of patients with ALL is low, the disease is considered ‘rare’, and Evoltra was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 February 2002.

The medicine can only be obtained with a prescription.

How is Evoltra used?

Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias. The recommended dose is 52 mg per square metre body surface area (calculated using the patient’s height and weight). It is given by infusion lasting two hours every day for five days. The treatment should be repeated every two to six weeks. Most patients who respond to treatment do so after one or two treatment cycles.

How does Evoltra work?

The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells). It belongs to the group of anti-cancer medicines called ‘antimetabolites’. Clofarabine is an ‘analogue’ of adenine, which is part of the fundamental genetic material of cells (DNA and RNA). This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase’ and ‘RNA reductase’. This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.

How has Evoltra been studied?

Evoltra has been examined in one study of 61 patients below 21 years of age with ALL. All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment. The average age of the treated patients was 12 years. The main measure of effectiveness was the number of patients who went into ‘remission’ (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels). The study did not compare Evoltra with any other treatments.

What benefit has Evoltra shown during the studies?

In the main study, 20% of the patients went into remission (12 out of 61). Overall, the patients in the study survived for an average of 66 weeks.

After treatment with Evoltra, 10 patients were able to go on to have a stem-cell transplant. This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow. Stem cells are cells that can develop into different types of cell.

What is the risk associated with Evoltra?

The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white-blood-cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness). For the full list of all side effects reported with Evoltra, see the package leaflet.

Evoltra should not be used in people who may be hypersensitive (allergic) to clofarabine or any of the other ingredients. Evoltra must not be given to patients with severe kidney or liver disease. Breast-feeding should be stopped before, during and after treatment with Evoltra.

Why has Evoltra been approved?

Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival. The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant. The Committee decided that Evoltra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

The company that makes Evoltra will look at the use of Evoltra in patients with kidney disease, and set up a registry to monitor the medicine’s side effects.

Other information about Evoltra

The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006. The marketing authorisation holder is Genzyme Europe B.V. After five years, the marketing authorisation was renewed for a further five years.

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

Name Language First published Last updated
Evoltra : EPAR - Summary for the public BG = bălgarski 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public ES = español 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public CS = čeština 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public DA = dansk 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public DE = Deutsch 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public ET = eesti keel 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public EL = elliniká 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public EN = English 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public FR = français 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public IT = italiano 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public LV = latviešu valoda 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public LT = lietuvių kalba 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public HU = magyar 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public MT = Malti 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public NL = Nederlands 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public PL = polski 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public PT = português 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public RO = română 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public SK = slovenčina 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public SL = slovenščina 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public FI = suomi 06/03/2009 12/04/2011
Evoltra : EPAR - Summary for the public SV = svenska 06/03/2009 12/04/2011

This EPAR was last updated on 08/04/2014 .

Authorisation details

Product details

Product details for Evoltra
NameEvoltra
Agency product numberEMEA/H/C/000613
Active substance

clofarabine

International non-proprietary name (INN) or common name

clofarabine

Therapeutic area Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01BB06
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 Evoltra
Marketing-authorisation holder

Genzyme Europe B.V.

Revision18
Date of issue of marketing authorisation valid throughout the European Union29/05/2006

Contact address:

Genzyme Europe B.V.
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

Product information

23/01/2014  Evoltra -EMEA/H/C/000613 -P46/0035

Name Language First published Last updated
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014
Evoltra : EPAR - Product Information SV = svenska 01/07/2009 07/02/2014

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
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  
Evoltra : EPAR - All Authorised presentations SV = svenska 25/05/2009  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Evoltra-H-C-613-P46-35 : EPAR - Assessment Report SV = svenska 08/04/2014  
Evoltra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 01/07/2009 07/02/2014
Evoltra-H-C-613-A46-33 : EPAR - Assessment Report SV = svenska 14/01/2013  
Evoltra-H-C-613-A46-36 : EPAR - Assessment Report SV = svenska 14/01/2013  

Initial marketing-authorisation documents

Name Language First published Last updated
Evoltra : EPAR - Procedural steps taken before authorisation SV = svenska 31/05/2007  
Evoltra : EPAR - Scientific Discussion SV = svenska 31/05/2007  

Authorised

This medicine is approved for use in the European Union

More information on Evoltra