Unituxin

dinutuximab

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

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

What is Unituxin and what is it used for?

Unituxin is a cancer medicine used to treat neuroblastoma, a nerve cell cancer, in children aged 12 months to 17 years.

Unituxin is used to treat children with ‘high-risk’ neuroblastoma, the form of the cancer that has a high chance of returning. Children treated with Unituxin will first have responded to chemotherapy and then received an additional treatment to clear out their bone marrow (myeloablative therapy) and a stem-cell transplantation.

Unituxin is given in combination with 3 other medicines: GM-CSF, interleukin-2 and isotretinoin.

Because the number of patients with neuroblastoma is low, the disease is considered ‘rare’, and Unituxin was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2011.

Unituxin contains the active substance dinutuximab.

How is Unituxin used?

Unituxin is given as an infusion (drip) into a vein. The daily dose depends on the child’s body surface area, and infusions are given over 10 hours. The patient also receives 3 other medicines: isotretinoin, GM-CSF and interleukin-2. Treatment lasts around 6 months, but not all the medicines are given every month. Unituxin is given on four consecutive days each month, in the first 5 months.

Because of the risk of severe allergic reactions with Unituxin, equipment and staff should be immediately available to resuscitate the patient if reactions occur. Patients should also be given an antihistamine medicine before the start of each Unituxin infusion to reduce the risk of a reaction.

Because pain is a common side of Unituxin treatment, patients are also given pain killers.

Unituxin is only for hospital use and treatment should be supervised by a doctor experienced in cancer treatments. The medicine can only be obtained with a prescription.

How does Unituxin work?

The active substance in Unituxin, dinutuximab, is a monoclonal antibody, designed to recognise and attach to a substance present at high levels in neuroblastoma cancer cells known as ganglioside GD2. When dinutuximab attaches to the gangliosides on neuroblastoma cells, it marks the cells out as targets for the immune system (the body’s natural defences), which then attacks them. In this way, the medicine can help clear out cancer cells remaining in the body following other treatments.

What benefits of Unituxin have been shown in studies?

A main study conducted in 230 patients with high-risk neuroblastoma showed that Unituxin (given with isotretinoin, GM-CSF and interleukin-2) was more effective than isotretinoin alone at keeping patients alive and preventing the re-emergence of their cancer. After around 3 years, 80% of patients receiving Unituxin were alive compared with 67% of patients receiving isotretinoin alone.

What are the risks associated with Unituxin?

The most common side effects with Unituxin (seen in more than 30% of patients) are: pain affecting any part of the body, hypotension (low blood pressure), hypersensitivity (allergic reactions), fever, urticaria (hives), capillary leak syndrome (a condition whereby fluid leaks from the blood vessels causing swelling and a fall in blood pressure), anaemia (low red blood cell counts), low platelet counts, low sodium and potassium levels, raised liver enzymes and low levels of white blood cells. For the full list of all side effects and restrictions, see the package leaflet.

Why is Unituxin approved?

Patients with high-risk neuroblastoma need aggressive therapy, which is often not sufficient to prevent the cancer from returning. A study of Unituxin in combination with isotretinoin, GM-CSF and interleukin-2 showed that the combination can improve outcomes in these patients, keeping them alive for longer and helping to prevent the disease from returning or getting worse.

Although side effects with Unituxin can be severe, and medication is required to prevent allergic reactions and pain, the medicine’s risks are considered acceptable given the severity of the disease. The number of patients who have to stop treatment because of side effects appears low and the side effects can be managed with appropriate measures.

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

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

A risk management plan has been developed to ensure that Unituxin 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 Unituxin, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Unituxin will carry out two studies to get more information about the safety of the medicine, including its long-term safety.

Further information can be found in the summary of the risk management plan.

Other information about Unituxin

The European Commission granted a marketing authorisation valid throughout the European Union for Unituxin on 14 August 2015.

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

Name Language First published Last updated
Unituxin : EPAR - Summary for the public BG = bălgarski 01/09/2015  
Unituxin : EPAR - Summary for the public ES = español 01/09/2015  
Unituxin : EPAR - Summary for the public CS = čeština 01/09/2015  
Unituxin : EPAR - Summary for the public DA = dansk 01/09/2015  
Unituxin : EPAR - Summary for the public DE = Deutsch 01/09/2015  
Unituxin : EPAR - Summary for the public ET = eesti keel 01/09/2015  
Unituxin : EPAR - Summary for the public EL = elliniká 01/09/2015  
Unituxin : EPAR - Summary for the public EN = English 01/09/2015  
Unituxin : EPAR - Summary for the public FR = français 01/09/2015  
Unituxin : EPAR - Summary for the public IT = italiano 01/09/2015  
Unituxin : EPAR - Summary for the public LV = latviešu valoda 01/09/2015  
Unituxin : EPAR - Summary for the public LT = lietuvių kalba 01/09/2015  
Unituxin : EPAR - Summary for the public HU = magyar 01/09/2015  
Unituxin : EPAR - Summary for the public MT = Malti 01/09/2015  
Unituxin : EPAR - Summary for the public NL = Nederlands 01/09/2015  
Unituxin : EPAR - Summary for the public PL = polski 01/09/2015  
Unituxin : EPAR - Summary for the public PT = português 01/09/2015  
Unituxin : EPAR - Summary for the public RO = română 01/09/2015  
Unituxin : EPAR - Summary for the public SK = slovenčina 01/09/2015  
Unituxin : EPAR - Summary for the public SL = slovenščina 01/09/2015  
Unituxin : EPAR - Summary for the public FI = suomi 01/09/2015  
Unituxin : EPAR - Summary for the public SV = svenska 01/09/2015  
Unituxin : EPAR - Summary for the public HR = Hrvatski 01/09/2015  
Name Language First published Last updated
Unituxin : EPAR - Risk-management-plan summary (English only) 01/09/2015  

This EPAR was last updated on 01/09/2015 .

Authorisation details

Product details

Product details for Unituxin
NameUnituxin
Agency product numberEMEA/H/C/002800
Active substance

dinutuximab

International non-proprietary name (INN) or common name

dinutuximab

Therapeutic area Neuroblastoma
Anatomical therapeutic chemical (ATC) code L01XC
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 Unituxin
Marketing-authorisation holder

United Therapeutics Europe Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union14/08/2015

Contact address:

United Therapeutics Europe Ltd
Uniter House 
Curfew Bell Road 
Chertsey 
Surrey 
KT16 9FG 
United Kingdom

Product information

Product information

14/08/2015  Unituxin -EMEA/H/C/002800

Name Language First published Last updated
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  
Unituxin : EPAR - Product Information EN = English 01/09/2015  

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
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  
Unituxin : EPAR - All Authorised presentations EN = English 01/09/2015  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Unituxin : EPAR - Public assessment report EN = English 01/09/2015  
CHMP summary of positive opinion for Unituxin EN = English 22/05/2015