Glivec

imatinib

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About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Glivec?

Glivec is a medicine that contains the active substance imatinib. It is available as capsules (50 and 100 mg) and tablets (100 and 400 mg).

What is Glivec used for?

Glivec is an anticancer medicine. It is used to treat the following diseases:

  • 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. Glivec 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. Glivec 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 anticancer 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. Glivec 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. Glivec 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. Glivec 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 (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs. Glivec is used to treat adults with GIST that cannot be removed with surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal;
  • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Glivec 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.

The medicine can only be obtained with a prescription.

How is Glivec used?

Glivec treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. Glivec 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 Glivec work?

The active substance in Glivec, 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, Glivec helps to control cell division.

How has Glivec been studied?

For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children. These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines). This study measured how long the patients lived without their cancer getting worse.

For ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly diagnosed patients.

For GIST, Glivec has been examined in two main studies. One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size. This study did not compare Glivec with any other medicines. The other study compared Glivec with placebo (a dummy treatment) in 713 patients whose cancer had been removed with surgery. This study measured how long the patients lived without their cancer coming back. 

For MD / MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines. These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell. 

What benefit has Glivec shown during the studies?

Glivec was more effective than the comparator medicines. In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine. Glivec was also better than standard chemotherapy in patients with ALL. In patients with GIST that had been removed with surgery, patients taking Glivec lived for longer than those taking placebo without their cancer coming back. In the non-comparative studies of CML, ALL and GIST, between 26 and 96% of patients showed a response to Glivec. Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.

What is the risk associated with Glivec?

The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red-blood-cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, oedema (fluid retention), rash, muscle spasm and cramps, muscle and joint pain, and fatigue (tiredness). For the full list of all side effects reported with Glivec, see the package leaflet. 

Glivec must not be used in people who are hypersensitive (allergic) to imatinib or any of the other ingredients.

Why has Glivec been approved?

The CHMP decided that Glivec’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Glivec

The European Commission granted a marketing authorisation valid throughout the European Union for Glivec on 7 November 2001.

Name Language First published Last updated
Glivec : EPAR - Summary for the public BG = bălgarski 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public ES = español 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public CS = čeština 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public DA = dansk 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public DE = Deutsch 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public ET = eesti keel 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public EL = elliniká 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public EN = English 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public FR = français 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public IT = italiano 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public LV = latviešu valoda 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public LT = lietuvių kalba 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public HU = magyar 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public MT = Malti 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public NL = Nederlands 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public PL = polski 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public PT = português 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public RO = română 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public SK = slovenčina 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public SL = slovenščina 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public FI = suomi 18/08/2009 24/07/2013
Glivec : EPAR - Summary for the public SV = svenska 18/08/2009 24/07/2013

This EPAR was last updated on 10/06/2016 .

Authorisation details

Product details

Product details for Glivec
NameGlivec
Agency product numberEMEA/H/C/000406
Active substance

imatinib

International non-proprietary name (INN) or common name

imatinib

Therapeutic area Leukemia, Myelogenous, Chronic, BCR-ABL PositiveGastrointestinal Stromal TumorsMyelodysplastic-Myeloproliferative DiseasesDermatofibrosarcomaPrecursor Cell Lymphoblastic Leukemia-LymphomaHypereosinophilic Syndrome
Anatomical therapeutic chemical (ATC) code L01XE01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Glivec
Marketing-authorisation holder

Novartis Europharm Ltd

Revision28
Date of issue of marketing authorisation valid throughout the European Union07/11/2001

Contact address:

Novartis Europharm Ltd
Frimley Business Park
Camberley
GU16 7SR
United Kingdom

Product information

Product information

11/05/2016  Glivec -EMEA/H/C/000406 -IAIN/0102

Name Language First published Last updated
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016
Glivec : EPAR - Product Information SV = svenska 18/08/2009 10/06/2016

Contents

  • 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.


Name Language First published Last updated
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  
Glivec : EPAR - All Authorised presentations SV = svenska 28/10/2005  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Glivec 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-PDGFRa rearrangement.

The effect of Glivec on the outcome of bone-marrow transplantation has not been determined.

Glivec 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 Glivec 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 Glivec 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

Authorised

This medicine is approved for use in the European Union

More information on Glivec

This product is no longer an orphan medicine. It was originally designated an orphan medicine for the following orphan indications:

Glivec for treatment of chronic myeloid leukaemia was withdrawn from the Community Register of designated orphan medicinal products in November 2011 at the end of the period of market exclusivity.

Glivec in in all other orphan indications was withdrawn from the Community Register of designated orphan medicinal products in April 2012 upon request of the marketing authorisation holder.