Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor (PDGFR) gene rearrangements.

This is written in the approval document as:

Glivec is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

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 (+)	PDGFRA rearrangements	Myelodysplastic Syndromes	Imatinib
Sensitivity (+)	PDGFRB rearrangements	Myelodysplastic Syndromes	Imatinib
Sensitivity (+)	PDGFRA rearrangements	Myeloproliferative Neoplasm	Imatinib
Sensitivity (+)	PDGFRB rearrangements	Myeloproliferative Neoplasm	Imatinib