# Acute lymphoblastic leukaemia

The EU has approved 18 indications of 8 drugs in acute lymphoblastic leukaemia. 15 of them need a biomarker result: BCR::ABL1 (7), CD19 (6) and CD22 (2).

## Approved indications

### BCR::ABL1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | + chemotherapy | 1st line | Children and adolescents only |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | + chemotherapy | 1st line | - |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | Philadelphia chromosome (BCR::ABL1 translocation) | + reduced-intensity chemotherapy | 1st line | - |
| [Dasatinib](https://oncolabels.com/drugs/dasatinib) (Sprycel, Dasatinib Accord Healthcare) | BCR::ABL1 fusion | Monotherapy | 2nd line | Resistance or intolerance to prior therapy |
| [Imatinib](https://oncolabels.com/drugs/imatinib) (Glivec) | Philadelphia chromosome (bcr-abl) | Monotherapy | 2nd line | Relapsed or refractory disease |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | Philadelphia chromosome (BCR::ABL1 translocation) | Monotherapy | 2nd line | Resistant to dasatinib, or intolerant to dasatinib and subsequent treatment with imatinib is not clinically appropriate |
| [Ponatinib](https://oncolabels.com/drugs/ponatinib) (Iclusig) | T315I, Philadelphia chromosome-positive | Monotherapy | Any line | - |

### CD19-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-negative | Monotherapy | 1st line | B-cell precursor ALL only; In first or second complete remission with minimal residual disease (MRD) ≥ 0.1% Ambiguous in the label (line of therapy): check the SmPC. |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-negative | Monotherapy | Consolidation | B-cell precursor ALL only; Children and adolescents only; Aged 1 month or older; high-risk |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-negative | Monotherapy | Consolidation | B-cell precursor ALL only |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-negative | Monotherapy | 2nd line | B-cell precursor ALL only |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-negative | Monotherapy | 2nd line | B-cell precursor ALL only; Children and adolescents only; After at least two prior therapies, or prior allogeneic haematopoietic stem cell transplantation; Aged 1 month or older |
| [Blinatumomab](https://oncolabels.com/drugs/blinatumomab) (Blincyto) | CD19-positive, Philadelphia chromosome-positive | Monotherapy | 3rd line+ | B-cell precursor ALL only; Failed treatment with at least 2 tyrosine kinase inhibitors (TKIs); No alternative treatment options |

### CD22-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Inotuzumab ozogamicin](https://oncolabels.com/drugs/inotuzumab-ozogamicin) (Besponsa) | CD22-positive | Monotherapy | 2nd line | B-cell precursor ALL only; Relapsed or refractory disease; patients with Ph+ disease should have failed treatment with at least 1 TKI |
| [Inotuzumab ozogamicin](https://oncolabels.com/drugs/inotuzumab-ozogamicin) (Besponsa) | CD22-positive | Monotherapy | 2nd line | B-cell precursor ALL only; Children and adolescents only; In first relapse after allo-HSCT, or after any first relapse in VHR disease, or after a second or greater relapse, or refractory disease; patients with Ph+ disease should have exhausted relevant BCR-ABL targeting treatment options; Aged 1 year and older |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Brexucabtagene autoleucel](https://oncolabels.com/drugs/brexucabtagene-autoleucel) (Tecartus) | None | Monotherapy | 2nd line | B-cell precursor ALL only; 26 years of age and above |
| [Obecabtagene autoleucel](https://oncolabels.com/drugs/obecabtagene-autoleucel) (Aucatzyl) | None | Monotherapy | 2nd line | B-cell precursor ALL only; Relapsed or refractory disease; 26 years of age and above |
| [Tisagenlecleucel](https://oncolabels.com/drugs/tisagenlecleucel) (Kymriah) | None | Monotherapy | 2nd line | B-cell precursor ALL only; Refractory, in relapse post-transplant or in second or later relapse; Up to and including 25 years of age |

## Label wording

- **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)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Acute lymphoblastic leukaemia, 2nd line: “Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Dasatinib** (Sprycel, Dasatinib Accord Healthcare), Acute lymphoblastic leukaemia, 1st line: “newly diagnosed Ph+ ALL in combination with chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, 2nd line: “BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, 3rd line+: “BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, 1st line: “BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, 2nd line: “BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, consolidation: “BLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Blinatumomab** (Blincyto), Acute lymphoblastic leukaemia, consolidation: “BLINCYTO is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf)
- **Tisagenlecleucel** (Kymriah), Acute lymphoblastic leukaemia, 2nd line: “Paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kymriah-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)
- **Brexucabtagene autoleucel** (Tecartus), Acute lymphoblastic leukaemia, 2nd line: “Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf)
- **Inotuzumab ozogamicin** (Besponsa), Acute lymphoblastic leukaemia, 2nd line: “BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf)
- **Inotuzumab ozogamicin** (Besponsa), Acute lymphoblastic leukaemia, 2nd line: “BESPONSA is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B-cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf)
- **Obecabtagene autoleucel** (Aucatzyl), Acute lymphoblastic leukaemia, 2nd line: “Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/aucatzyl-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/tumours/acute-lymphoblastic-leukaemia