# Ponatinib

Ponatinib (Iclusig, Incyte Biosciences Distribution B.V.) has 7 EU-approved indications in 2 tumour types. Each needs a biomarker result: BCR::ABL1 (7).

## Approved indications

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Philadelphia chromosome (BCR::ABL1 translocation) | + reduced-intensity chemotherapy | 1st line | - |
| Philadelphia chromosome (BCR::ABL1 translocation) | Monotherapy | 2nd line | Resistant to dasatinib, or intolerant to dasatinib and subsequent treatment with imatinib is not clinically appropriate |
| T315I, Philadelphia chromosome-positive | Monotherapy | Any line | - |

### Chronic myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BCR::ABL1 fusion (defines the disease) | Monotherapy | 2nd line | Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate |
| BCR::ABL1 fusion (defines the disease) | Monotherapy | 2nd line | Chronic phase only; Children and adolescents only; Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate; Aged 6 years or older |
| BCR::ABL1 T315I | Monotherapy | Any line | - |
| BCR::ABL1 T315I | Monotherapy | Any line | Chronic phase only; Children and adolescents only; Aged 6 years or older |

## Products

### Iclusig

- Company: Incyte Biosciences Distribution B.V.
- Target: Pan BCR-ABL tyrosine kinase inhibitor
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA05
- EU approval: 1 Jul 2013
- Label revised: 31 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/iclusig-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/iclusig

Mechanism (SmPC section 5.1): Binds with high affinity to native BCR-ABL and mutant forms of the ABL kinase, inhibiting their kinase activity.

## Label wording

- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, 2nd line: “chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, any line: “chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, 2nd line: “Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, any line: “Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Acute lymphoblastic leukaemia, 1st line: “Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, 2nd line: “chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf)
- **Ponatinib** (Iclusig), Chronic myeloid leukaemia, any line: “chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iclusig-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/ponatinib