Imatinib Koanaa

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imatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Imatinib Koanaa is a cancer medicine for treating adults and children with:

  • 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 Koanaa 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 Koanaa is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant. It is also used in adults and children in the ‘chronic phase’ of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase’ and ‘blast crisis’);
  • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. Imatinib Koanaa is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines.

This medicine is also used for treating adults with:

  • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib Koanaa 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 Koanaa is used to treat adults with HES or CEL who have a specific re‑arrangement of two genes called FIP1L1 and PDGFRα;
  • gastrointestinal stromal tumours (GIST), a type of cancer that arises from uncontrolled cell growth of the supporting tissues of the stomach and bowels. Imatinib Koanaa is used when patients are ‘Kit (CD117) positive’. This means that the cancer cells have a specific protein called Kit (CD117) on their surface. Imatinib Koanaa is used when GIST cannot be removed with surgery, and/or when the cancer has spread to other parts of the body. It is also used to treat adult patients in which the cancer is likely to come back after surgical removal of GIST;
  • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Imatinib Koanaa 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 Koanaa is a type of ‘generic medicine’ called a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but the medicine is presented in a different way. While the reference medicine, Glivec, is available as film-coated tablets, Imatinib Koanaa is available as an oral solution (a liquid to be drunk).

Imatinib Koanaa contains the active substance imatinib.

This EPAR was last updated on 01/10/2021

Authorisation details

Product details
Name
Imatinib Koanaa
Agency product number
EMEA/H/C/005595
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Koanaa Healthcare GmbH
Date of issue of marketing authorisation valid throughout the European Union
22/09/2021
Contact address

Fehrgasse 7
2401 Fischamend
Austria

Product information

22/09/2021 Imatinib Koanaa - EMEA/H/C/005595 -

Contents

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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-PDGFRα 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.

Assessment history

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