Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

This is written in the approval document as:

Glivec is indicated for the treatment of the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

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
2001-11-07	European Medicines Agency	Indication received approval from the European Commission.