Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

This is written in the approval document as:

Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of 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 (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Imatinib