Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2009-04-29	European Medicines Agency	Indication received approval from the European Commission.