Glivec
Authorised
imatinib
Medicine
Human
Authorised
This is a summary of the European public assessment report (EPAR) for Glivec. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for 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).
Glivec is an anticancer medicine. It is used to treat the following diseases:
The medicine can only be obtained with a prescription.
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.
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.
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 Ph+ 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. It has also been examined in a fourth main study involving 160 children and young people aged 1 to 22 years.
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.
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 Ph+ 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, Ph+ ALL and GIST, between 26 and 96% of patients showed a response to Glivec. In the study of patients aged 1 to 22 years who had Ph+ ALL, Glivec was shown to increase how long the patients lived without any major events (such as a relapse).
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.
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, periorbital oedema (swelling around the eyes), rash, muscle spasm and cramps, muscle, bone and joint pain, fluid retention 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.
The CHMP decided that Glivec’s benefits are greater than its risks and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Glivec on 7 November 2001.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
Glivec is indicated for the treatment of
The effect of Glivec on the outcome of bone-marrow transplantation has not been determined.
Glivec is indicated for:
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.