# CD19 in acute lymphoblastic leukaemia

6 EU-approved indications in acute lymphoblastic leukaemia need a CD19 result: blinatumomab (2nd line), blinatumomab (3rd line+), blinatumomab (1st line), blinatumomab (2nd line), blinatumomab (consolidation) and blinatumomab (consolidation).

## Approved indications

### 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 |

## Label wording

- **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)

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/cd19