Oncaspar
Authorised
This medicine is authorised for use in the European Union
pegaspargase
MedicineHumanAuthorised
- 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.
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.
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.
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.
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.
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.
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.
Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.
Product information
Latest procedure affecting product information:
II/0053/G
16/05/2024
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).
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 agentsTherapeutic 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.
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