Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized imatinib for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD 117) positive gastrointestinal stromal tumors (GIST). Patients who have a low or very low risk of recurrence should not received adjuvant treatment.

This is written in the approval document as:

Glivec is indicated for the treatment of 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.

Citation

Novartis Europharm Limited. Glivec (imatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf. Revised November 2023. Accessed March 7, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib