# Blinatumomab

Blinatumomab (Blincyto, Amgen Europe B.V.) has 6 EU-approved indications in 1 tumour type. Each needs a biomarker result: CD19 (6).

## Approved indications

### Acute lymphoblastic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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. |
| CD19-positive, Philadelphia chromosome-negative | Monotherapy | Consolidation | B-cell precursor ALL only; Children and adolescents only; Aged 1 month or older; high-risk |
| CD19-positive, Philadelphia chromosome-negative | Monotherapy | Consolidation | B-cell precursor ALL only |
| CD19-positive, Philadelphia chromosome-negative | Monotherapy | 2nd line | B-cell precursor ALL only |
| 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 |
| 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 |

## Products

### Blincyto

- Company: Amgen Europe B.V.
- Target: CD19 × CD3 bispecific antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX07
- EU approval: 23 Nov 2015
- Label revised: 22 Sep 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/blincyto-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/blincyto

Mechanism (SmPC section 5.1): Binds CD19 on B cells and CD3 on T cells to form a cytolytic synapse, activating endogenous T cells to induce targeted lysis of CD19-positive cells.

## 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/drugs/blinatumomab