Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Date of authorisation: 14/01/2016, Revision: 20, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

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

It contains the active substance pegaspargase.

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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.

Oncaspar can only be obtained with a prescription and 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 more information about using Oncaspar, see the package leaflet or contact your doctor or pharmacist.

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 during that period. 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) include signs of liver problems (raised levels of liver enzymes and bilirubin in the blood), reduced blood clotting, high levels of fats in the blood, high levels of blood glucose and low levels of white blood cells accompanied by fever. For the full list of side effects of Oncaspar, see the package leaflet.

Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis (including pancreatitis caused by previous asparaginase treatments) or patients 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 authorised in the EU?

Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to 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 considered manageable

The European Medicines Agency therefore decided that Oncaspar’s benefits are greater than its risks and it can be authorised for use in the EU.

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

The European Medicines Agency 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?

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.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oncaspar have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Oncaspar are continuously monitored. Side effects reported with Oncaspar are carefully evaluated and any necessary action taken to protect patients.

Other information about Oncaspar

Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.

Oncaspar : EPAR - Medicine overview

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Oncaspar : EPAR - Risk management plan

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Product information

Oncaspar : EPAR - Product Information

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Latest procedure affecting product information:

N/0000344088

04/05/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Oncaspar : EPAR - All Authorised presentations

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Product details

Name of medicine

Oncaspar

Active substance

pegaspargase

International non-proprietary name (INN) or common name

pegaspargase

Therapeutic area (MeSH)

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Anatomical therapeutic chemical (ATC) code

L01XX24

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.

Authorisation details

EMA product number

EMEA/H/C/003789

Marketing authorisation holder

Les Laboratoires Servier

Les Laboratoires Servier 50 rue Carnot F-92284 Suresnes Cedex France

Marketing authorisation issued

14/01/2016

Revision

20

Assessment history

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Changes since initial authorisation of medicine

Oncaspar : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (158.54 KB - PDF)

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07/05/2026

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Oncaspar : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (250.79 KB - PDF)

First published:

15/08/2016

Last updated:

25/10/2024

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Oncaspar-H-C-003789-P46-008 : EPAR - Assessment report

Adopted

Reference Number:

EMA/56595/2024

English (EN) (854.01 KB - PDF)

First published:

15/02/2024

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Oncaspar-PSUSA-00010457-201907 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/316519/2020

English (EN) (129.68 KB - PDF)

First published:

16/06/2020

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Oncaspar-PSUSA-00010457-201807 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/257623/2019

English (EN) (66.46 KB - PDF)

First published:

16/05/2019

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Initial marketing authorisation documents

Oncaspar : EPAR - Public assessment report

Adopted

Reference Number:

EMA/826135/2016

English (EN) (7.05 MB - PDF)

First published:

29/01/2016

Last updated:

29/01/2016

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CHMP summary of opinion for Oncaspar

Adopted

Reference Number:

EMA/CHMP/734982/2015

English (EN) (70.97 KB - PDF)

First published:

20/11/2015

Last updated:

20/11/2015

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News on Oncaspar

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015

20/11/2015

Topics

• Medicines

This page was last updated on

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