# Imatinib

Imatinib (Glivec, Novartis Europharm Limited) has 9 EU-approved indications in 5 tumour types. 8 need a biomarker result: BCR::ABL1 (4), KIT (2), FIP1L1::PDGFRA (1) and PDGFR (1).

## Approved indications

### Gastrointestinal stromal tumour

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| KIT-positive | Monotherapy | Adjuvant | After resection of Kit (CD117)-positive GIST; Significant risk of relapse; patients who have a low or very low risk of recurrence should not receive adjuvant treatment |
| KIT-positive | Monotherapy | Advanced | - |

### Soft tissue sarcoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Dermatofibrosarcoma protuberans only; Not eligible for surgery (for recurrent and/or metastatic DFSP) |

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Philadelphia chromosome (bcr-abl) | + chemotherapy | 1st line | - |
| Philadelphia chromosome (bcr-abl) | Monotherapy | 2nd line | Relapsed or refractory disease |

### Chronic myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Philadelphia chromosome (bcr-abl) | Monotherapy | 1st line | Bone marrow transplantation is not considered as the first line of treatment |
| Philadelphia chromosome (bcr-abl) | Monotherapy | Any line | Failure of interferon-alpha therapy (for chronic phase) |

### Myeloid/lymphoid neoplasms with eosinophilia and TK fusions

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PDGFR fusion | Monotherapy | Any line | - |
| FIP1L1-PDGFRalpha rearrangement | Monotherapy | Advanced | - |

## Products

### Glivec

- Company: Novartis Europharm Limited
- Target: BCR-ABL tyrosine kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA01
- EU approval: 7 Nov 2001
- Label revised: 27 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/glivec-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/glivec
- Biosimilars and generics: Imatinib Accord, Imatinib Teva

Mechanism (SmPC section 5.1): Imatinib inhibits the BCR-ABL tyrosine kinase and the receptor kinases KIT, PDGFRα/β, DDR1/DDR2 and CSF-1R, blocking cellular events driven by their activation.

## Label wording

- **Imatinib** (Glivec), Chronic myeloid leukaemia, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Chronic myeloid leukaemia, any line: “adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Acute lymphoblastic leukaemia, 1st line: “adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Acute lymphoblastic leukaemia, 2nd line: “adult patients with relapsed or refractory Ph+ ALL as monotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Myeloid/lymphoid neoplasms with eosinophilia and TK fusions, any line: “adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Myeloid/lymphoid neoplasms with eosinophilia and TK fusions, advanced: “adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Gastrointestinal stromal tumour, advanced: “the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Gastrointestinal stromal tumour, adjuvant: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)
- **Imatinib** (Glivec), Soft tissue sarcoma, advanced: “the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/imatinib