Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with a FIP1L1::PDGFRA rearrangement.

This is written in the approval document as:

Glivec is indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR_ rearrangement.

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 (+)	FIP1L1::PDGFRA	Chronic Eosinophilic Leukemia, NOS	Imatinib