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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	PDGFRA rearrangements	Myelodysplastic Syndromes	Imatinib
EMA (1)	PDGFRB rearrangements	Myelodysplastic Syndromes	Imatinib
EMA (1)	PDGFRA rearrangements	Myeloproliferative Neoplasm	Imatinib
EMA (1)	PDGFRB rearrangements	Myeloproliferative Neoplasm	Imatinib