Imatinib Koanaa

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

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European Public Assessment Report (EPAR) for Imatinib Koanaa is updated to indicate that the marketing authorisation is no longer valid.

Imatinib Koanaa : EPAR - Medicine overview

Reference Number: EMA/429510/2021

Imatinib Koanaa : EPAR - Risk-management-plan summary

Product information

Imatinib Koanaa : EPAR - Product information

Imatinib Koanaa : EPAR - All authorised presentations

Product details

• Name of medicine:
  Imatinib Koanaa
• Active substance:
  imatinib mesilate
• International non-proprietary name (INN) or common name:
  imatinib
• Therapeutic area (MeSH):
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic-Myeloproliferative Diseases
  • Hypereosinophilic Syndrome
  • Dermatofibrosarcoma
  • Gastrointestinal Stromal Tumors
• Anatomical therapeutic chemical (ATC) code:
  L01EA01

Pharmacotherapeutic group

Antineoplastic agents

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005595
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Koanaa Healthcare GmbH

  Fehrgasse 7; 2401 Fischamend; Austria

• Opinion adopted:
  22/07/2021
• Marketing authorisation issued:
  22/09/2021
• Withdrawal of marketing authorisation:
  31/08/2023

Assessment history

Initial marketing authorisation documents

Imatinib Koanaa : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/444756/2021

CHMP summary of positive opinion for Imatinib Koanaa

Adopted Reference Number: EMA/338599/2021