Blincyto is a cancer medicine used to treat a type of blood cancer that affects B cells (a type of white blood cell) called B-precursor acute lymphoblastic leukaemia (ALL). It is used in adults whose cancer cells have a protein called CD19 on their surface (CD19-positive) and is: - Philadelphia chromosome-positive (Ph-positive), which means that the cancer cells have an abnormal chromosome called the Philadelphia chromosome. Blincyto is used if the cancer has not responded to previous treatments with at least two medicines known as tyrosine kinase inhibitors and there are no other treatment options available; - Philadelphia chromosome-negative (Ph-negative), where the cancer cells do not have an abnormal Philadelphia chromosome. Blincyto is used in adults who still have a small number of cancer cells remaining after previous treatment (referred to as minimal residual disease). Blincyto is also used in adults with newly diagnosed Ph-negative ALL when the cancer cells have a protein called CD19 on their surface (CD19-positive). It is used as part of consolidation therapy (treatment to improve remission). Blincyto is used in children aged 1 month and older with Ph-negative ALL, CD19-positive B-cell precursor ALL. It is used when the cancer: - has not improved or has come back after two previous therapies or has come back following an allogenic haematopoietic stem cell transplantation (a procedure where the patient’s bone marrow is replaced by stem cells from a donor to form new bone marrow that produces healthy cells); - has come back for the first time and is considered high risk. Blincyto is used as part of consolidation therapy. ALL is rare, and Blincyto was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 July 2009. Blincyto contains the active substance blinatumomab.
Therapeutic Indication
### Therapeutic indication 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. 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%. 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. 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). 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.
Therapeutic Area (MeSH)
ATC Code
L01FX07
ATC Item
blinatumomab
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| blinatumomab | N/A | 贝林妥欧单抗 |
EMA Name
Blincyto
Medicine Name
Blincyto
Aliases
N/A