What is Oncaspar and Pegaspargasi used for?
Oncaspar is used in adults and children for the treatment of acute lymphoblastic leukemia (ALL), a tumor that originates in a particular type of white blood cells (lymphoblasts), in combination with other anticancer drugs. Contains the active ingredient pegaspargase.
How is Oncaspar - Pegaspargasi used?
Oncaspar is normally administered every 14 days by intramuscular injection or infusion (drip into a vein), in a dose variable according to age and body surface area.
The prescription and administration of the medicine should only be carried out by healthcare professionals experienced in the use of anticancer drugs. The healthcare professional should administer the medicine in a hospital setting with the availability of resuscitation facilities.
For more information, see the package leaflet. Oncaspar can only be obtained with a prescription and is available as a solution for injection or infusion in a bottle.
How does Oncaspar - Pegaspargasi work?
The active ingredient (pegaspargase) contains the enzyme asparaginase, which acts by degrading the amino acid asparagine and reducing its levels in the blood. Cancer cells need this amino acid to grow and multiply, so its reduction in blood causes cell death. Unlike cancer cells, normal cells can produce asparagine by themselves and are less affected by the action of the medicine.
The enzyme asparaginase contained in this medicine is combined with a chemical that slows down the elimination from the body and can reduce the risk of allergic reactions.
What benefits of Oncaspar - Pegaspargase have been shown in studies?
In a study of 118 children with a recent diagnosis of ALL, 75% of subjects treated with Oncaspar (in combination with other medicines) achieved remission and did not experience tumor recurrence or new cancer after 7 years. This figure compares with the 66% obtained by subjects treated with another asparaginase.
In another study conducted on 76 children who had a relapse of the tumor after a previous treatment, about 40% of patients treated with Oncaspar (some of whom were allergic to other asparaginase-based therapies) achieved remission, compared to 47 % of patients treated with a comparator based on asparaginase.
What are the risks associated with Oncaspar - Pegaspargasi?
The most common side effects of Oncaspar (which may affect more than 1 in 10 people) are allergic reactions (even serious), rash, hives, hyperglycaemia, pancreatitis (inflammation of the pancreas), diarrhea and abdominal pain. For the full list of all side effects reported with Oncaspar, see the package leaflet.
Oncaspar should not be used in patients with severe liver disease, in patients with a history of pancreatitis or in those who have had severe bleeding or blood clots following treatment with asparaginase. For the full list of limitations, see the package leaflet.
Why has Oncaspar - Pegaspargasi been approved?
Studies have shown that Oncaspar is effective in patients with ALL, including patients allergic to other asparaginase-containing medicines. Oncaspar also has the advantage of requiring a smaller number of injections, given that the medicine remains longer in the body than other asparaginases. However, data on adult patients are limited and the pharmaceutical company that markets the medicine has been asked to provide additional data on the benefits in this patient population.
Regarding the risks, the side effects of Oncaspar are similar to those caused by other asparaginase medicines and are manageable.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Oncaspar'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 Oncaspar - Pegaspargasi?
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 pharmaceutical company that markets Oncaspar will complete two additional clinical studies on the safety and efficacy of Oncaspar, which will make it possible to understand more clearly the benefits and risks of the medicine in question in adults and in patients with a recent diagnosis.
Further information is available in the summary of the risk management plan.
More information on Oncaspar - Pegaspargasi
For more information on Oncaspar therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
