Metastatic malignant gastrointestinal stromal tumours (GIST) with Kit (CD 117) positive

Active Ingredient: Imatinib

Indication for Imatinib

Population group: only adults (18 years old or older)

Imatinib 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.

For this indication, competent medicine agencies globally authorize below treatments:

400-800 mg in 1-2 divided doses daily


Dosage regimens

Oral, between 200 milligrams imatinib and 400 milligrams imatinib, 2 times daily.

Detailed description

The recommended dose of imatinib is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.

Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose.

Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression. At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). The effect of stopping treatment after achieving a response has not been investigated.

The recommended dose of imatinib is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST. Optimal treatment duration is not yet established. Length of treatment in the clinical trial supporting this indication was 36 months.

Dosage considerations

The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.

Active ingredient


Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.

Read more about Imatinib

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