This is a summary of the European public assessment report (EPAR) for Imatinib Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imatinib Accord.
For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Imatinib Accord and what is it used for?
Imatinib Accord is an anticancer medicine that contains the active substance imatinib. It is used to treat the following diseases:
- in children to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control. Imatinib Accord is used when the patients are ‘Philadelphia-chromosome-positive’ (Ph+). This means that some of their genes have re‑arranged themselves to form a special chromosome called the Philadelphia chromosome. Imatinib Accord is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone-marrow transplant. It is also used in children in the ‘chronic phase’ of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase’ and ‘blast crisis’);
- in adults with Ph+ CML in blast crisis;
- Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. Imatinib Accord is used in combination with other anticancer medicines in adults who have been newly diagnosed with Ph+ ALL. It is also used alone to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
- myelodysplastic or myeloproliferative diseases (MD / MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib Accord is used to treat adults with MD / MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
- advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. Imatinib Accord is used to treat adults with HES or CEL who have a specific re‑arrangement of two genes called FIP1L1 and PDGFRα;
- dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Imatinib Accord is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Imatinib Accord is a ‘generic medicine’. This means that Imatinib Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Glivec.
- How is Imatinib Accord used?
Imatinib Accord is available as tablets (100 and 400 mg). It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. Imatinib Accord is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut. The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day. For more information, see the package leaflet.
- How does Imatinib Accord work?
The active substance in Imatinib Accord, imatinib, is a protein tyrosine-kinase inhibitor. This means that it blocks some specific enzymes known as tyrosine kinases. These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. By blocking these receptors, Imatinib Accord helps to control cell division.
- How has Imatinib Accord been studied?
Because Imatinib Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
- What are the benefits and risks of Imatinib Accord?
Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
- Why is Imatinib Accord approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec. Therefore, the CHMP’s view was that, as for Glivec, the benefit outweighs the identified risk. The Committee recommended that Imatinib Accord be approved for use in the EU.
- What measures are being taken to ensure the safe and effective use of Imatinib Accord?
A risk-management plan has been developed to ensure that Imatinib Accord 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 Imatinib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
- Other information about Imatinib Accord
The European Commission granted a marketing authorisation valid throughout the EU for Imatinib Accord on 1 July 2013.
This EPAR was last updated on 03/02/2016 .
25/01/2016 Imatinib Accord -EMEA/H/C/002681 -IAIN/0009/G
- 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.
Imatinib Accord is indicated for the treatment of:
- paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone-marrow transplantation is not considered as the first line of treatment;
- paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;
- adult patients with Ph+ CML in blast crisis;
- adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) integrated with chemotherapy;
- adult patients with relapsed or refractory Ph+ ALL as monotherapy;
- adult patients with myelodysplastic / myeloproliferative diseases (MDS / MPD) associated with platelet-derived-growth-factor-receptor (PDGFR)-gene re-arrangements
- adult patients with advanced hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement;
- adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and / or metastatic DFSP who are not eligible for surgery.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Imatinib Accord : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||13/11/2013||03/02/2016|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Imatinib Accord : EPAR - Public assessment report||HR = Hrvatski||10/07/2013|
|CHMP summary of positive opinion for Imatinib Accord||HR = Hrvatski||26/04/2013|