On 31 August 2023, the European Commission withdrew the marketing authorisation for Imatinib Koanaa (imatinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Koanaa Healthcare GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Imatinib Koanaa was granted marketing authorisation in the EU on 22 September 2021 for the treatment of adults and children with: * chronic myeloid leukaemia (CML), in patients who are ‘Philadelphia chromosome positive’ (Ph\+), * Ph\+ acute lymphoblastic leukaemia (ALL). This medicine is also used for treating adults with: * myelodysplastic or myeloproliferative diseases (MD/MPD), * advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), * gastrointestinal stromal tumours (GIST), * dermatofibrosarcoma protuberans (DFSP). The marketing authorisation was initially valid for a 5\-year period. Imatinib Koanaa is a generic medicine of Glivec. There are other generic medicinal products of Glivec authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Imatinib Koanaa is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
Imatinib Koanaa 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. The effect of Imatinib on the outcome of bone marrow transplantation has not been determined. Imatinib Koanaa is indicated for * 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 treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. 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 GIST and DFSP and on recurrence\-free survival in adjuvant GIST. 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
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Imatinib Koanaa
Medicine Name
Imatinib Koanaa
Aliases
N/ANo risk management plan link.
