Oncaspar

pegaspargase

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

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

What is Oncaspar and what is it used for?

Oncaspar is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines. It contains the active substance pegaspargase.

How is Oncaspar used?

Oncaspar is normally given every 14 days by injection into a muscle or by infusion (drip) into a vein, with the dose depending on age and body surface area.

Only healthcare professionals with experience of cancer treatments should prescribe and give the medicine. The healthcare professional should give the medicine in a hospital where resuscitation equipment is available. For further information, see the package leaflet.

Oncaspar can only be obtained with a prescription and is available in a vial as a solution for infusion or injection.

How does Oncaspar work?

The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine. The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die. Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.

The asparaginase enzyme in this medicine is linked to a chemical which slows down its removal from the body and can reduce the risk of allergic reactions.

What benefits of Oncaspar have been shown in studies?

In a study in 118 children newly diagnosed with ALL, 75% of those treated with Oncaspar (in combination with other medicines) were free of the cancer after 7 years without having relapse or a new cancer. This compares with 66% of those treated with another asparaginase.

In another study of 76 children whose cancer returned after earlier treatment, around 40% of Oncaspar-treated patients (some of whom were allergic to other asparaginase treatments) were cleared of the cancer, compared with 47% of patients treated with an asparaginase comparator.

What are the risks associated with Oncaspar?

The most common side effects with Oncaspar (which may affect more than 1 in 10 people) are allergic reactions (including serious allergic reactions), hives, rash, high blood sugar levels, pancreatitis (inflammation of the pancreas), diarrhoea, and abdominal (belly) pain. For the full list of side effects reported with Oncaspar, see the package leaflet.

Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis or those who have had severe bleeding or serious blood clots following asparaginase treatment. For the full list of restrictions, see the package leaflet.

Why is Oncaspar approved?

Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to other medicines containing asparaginase. Oncaspar also comes with the advantage of requiring fewer injections as the medicine stays longer in the body than some other asparaginases. However, the data in adult patients were limited and the company that markets the medicine is to provide further data of its benefit in this group of patients.

As for its risks, the side effects of Oncaspar are similar to those of other asparaginase medicines and are manageable.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Oncaspar are greater than the 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 Oncaspar?

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

In addition, the company that markets Oncaspar will complete two more studies on the safety and effectiveness of Oncaspar, which will help further clarify the benefits and risks of this medicine in adults and in newly diagnosed patients.

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

Other information about Oncaspar

The European Commission granted a marketing authorisation valid throughout the European Union for Oncaspar on 14 January 2016.

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

Name Language First published Last updated
Oncaspar : EPAR - Summary for the public BG = bălgarski 29/01/2016  
Oncaspar : EPAR - Summary for the public ES = español 29/01/2016  
Oncaspar : EPAR - Summary for the public CS = čeština 29/01/2016  
Oncaspar : EPAR - Summary for the public DA = dansk 29/01/2016  
Oncaspar : EPAR - Summary for the public DE = Deutsch 29/01/2016  
Oncaspar : EPAR - Summary for the public ET = eesti keel 29/01/2016  
Oncaspar : EPAR - Summary for the public EL = elliniká 29/01/2016  
Oncaspar : EPAR - Summary for the public EN = English 29/01/2016  
Oncaspar : EPAR - Summary for the public FR = français 29/01/2016  
Oncaspar : EPAR - Summary for the public IT = italiano 29/01/2016  
Oncaspar : EPAR - Summary for the public LV = latviešu valoda 29/01/2016  
Oncaspar : EPAR - Summary for the public LT = lietuvių kalba 29/01/2016  
Oncaspar : EPAR - Summary for the public HU = magyar 29/01/2016  
Oncaspar : EPAR - Summary for the public MT = Malti 29/01/2016  
Oncaspar : EPAR - Summary for the public NL = Nederlands 29/01/2016  
Oncaspar : EPAR - Summary for the public PL = polski 29/01/2016  
Oncaspar : EPAR - Summary for the public PT = português 29/01/2016  
Oncaspar : EPAR - Summary for the public RO = română 29/01/2016  
Oncaspar : EPAR - Summary for the public SK = slovenčina 29/01/2016  
Oncaspar : EPAR - Summary for the public SL = slovenščina 29/01/2016  
Oncaspar : EPAR - Summary for the public FI = suomi 29/01/2016  
Oncaspar : EPAR - Summary for the public SV = svenska 29/01/2016  
Oncaspar : EPAR - Summary for the public HR = Hrvatski 29/01/2016  
Name Language First published Last updated
Oncaspar : EPAR - Risk-management-plan summary (English only) 29/01/2016  

This EPAR was last updated on 15/08/2016 .

Authorisation details

Product details

Product details for Oncaspar
NameOncaspar
Agency product numberEMEA/H/C/003789
Active substance

pegaspargase

International non-proprietary name (INN) or common name

pegaspargase

Therapeutic area Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01XX24
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.

Publication details

Publication details for Oncaspar
Marketing-authorisation holder

Baxalta Innovations GmbH

Revision2
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Contact address:

Baxalta Innovations GmbH
Industriestrasse 67 
1221 Vienna 
Austria

Product information

Product information

29/04/2016  Oncaspar -EMEA/H/C/003789 -N/0002

Name Language First published Last updated
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016
Oncaspar : EPAR - Product Information EN = English 29/01/2016 15/08/2016

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
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  
Oncaspar : EPAR - All Authorised presentations EN = English 29/01/2016  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Oncaspar : EPAR - Procedural steps taken and scientific information after authorisation EN = English 15/08/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Oncaspar : EPAR - Public assessment report EN = English 29/01/2016  
CHMP summary of opinion for Oncaspar EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union