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.
Therapeutic Indication
Imatinib Accord is indicated for the treatment of * adult and 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. * adult and paediatric patients with Ph\+ CML in chronic phase after failure of interferon\-alpha therapy, or in accelerated phase or blast crisis. * adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph\+ 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\-PDGFR? rearrangement. * adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. * the treatment of adult patients with Kit (CD 117\) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). * the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117\)\-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment The effect of imatinib on the outcome of bone marrow transplantation has not been determined. In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression\-free survival in CML, on haematological and cytogenetic response rates in Ph\+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re\-arrangements is very limited (see section 5\.1\). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Therapeutic Area (MeSH)
ATC Code
L01EA01
ATC Item
N/A
Pharmacotherapeutic Group
imatinib
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| imatinib | N/A | imatinib |
EMA Name
Imatinib Accord
Medicine Name
Imatinib Accord
Aliases
N/ANo risk management plan link.
