Glivec (imatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
Glivec is indicated for the treatment of adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.	2
Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.	1
Glivec is indicated for the treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.	1
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.	4
Glivec is indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRa rearrangement.	1
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).	1
Glivec is indicated for the treatment of the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (2)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Imatinib
EMA (1)	PDGFRA rearrangements	Myelodysplastic Syndromes	Imatinib
EMA (1)	PDGFRB rearrangements	Myelodysplastic Syndromes	Imatinib
EMA (1)	FIP1L1::PDGFRA	Chronic Eosinophilic Leukemia, NOS	Imatinib
EMA (2)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib
EMA (2)	BCR::ABL1	Chronic Myelogenous Leukemia	Imatinib
EMA (2)	BCR::ABL1	Acute Lymphoid Leukemia	Imatinib
EMA (1)	PDGFRA rearrangements	Myeloproliferative Neoplasm	Imatinib
EMA (1)	PDGFRB rearrangements	Myeloproliferative Neoplasm	Imatinib