CD19
6 EU-approved indications of 1 drug need a CD19 result, in 1 tumour type, most of them in acute lymphoblastic leukaemia.
Approved indications6
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Acute lymphoblastic leukaemia6 | ||||
Blincyto | Philadelphia chromosome-negative | Monotherapy | 1L | B-cell precursor ALL only; In first or second complete remission with minimal residual disease (MRD) ≥ 0.1% |
Blincyto | Philadelphia chromosome-negative | Monotherapy | Consol. | B-cell precursor ALL only; Children and adolescents only; Aged 1 month or older; high-risk |
Blincyto | Philadelphia chromosome-negative | Monotherapy | Consol. | B-cell precursor ALL only |
Blincyto | Philadelphia chromosome-negative | Monotherapy | 2L | B-cell precursor ALL only |
Blincyto | Philadelphia chromosome-negative | Monotherapy | 2L | 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 |
Blincyto | Philadelphia chromosome-positive | Monotherapy | 3L+ | B-cell precursor ALL only; Failed treatment with at least 2 tyrosine kinase inhibitors (TKIs); No alternative treatment options |
CD19 by tumour
Label wording6
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Blinatumomab (Blincyto)
BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
- Blinatumomab (Blincyto)
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.
- Blinatumomab (Blincyto)
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%.
- Blinatumomab (Blincyto)
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.
- Blinatumomab (Blincyto)
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).
- Blinatumomab (Blincyto)
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.