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Therapeutic Blinatumomab antibody from the original Blincyto® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
CD19 , CD3 |
Bispecific Antibody |
Blincyto® |
0,0125 mg/mL |
– |
0,002 mg |
-80°C |
07/2027 |
1.020,00 € |
| Drug name | Blyncito® |
| INN | Blinatumomab |
| API type | Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents, other Antineoplastic agents |
| ATC code | L01XC19 |
| Target of antibody | CD19, CD3 |
| General function | Blinatumomab is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blinatumomab is indicated as monotherapy for the treatment of adults and patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Blinatumomab is a bispecific T-cell engager molecule that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells. The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target cells. Blinatumomab mediates the formation of a cytolytic synapse between the T-cell and the tumour cell, releasing proteolytic enzymes to kill both proliferating and resting target cells. Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Consistent immune-pharmacodynamic responses were observed in patients studied. During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterised by T-cell activation and initial redistribution, rapid peripheral B-cell depletion, and transient cytokine elevation. |
| Original license holder | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Marketing authorisation numbers | EU/1/15/1047/001 |
| Marketing authorisation holder | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Name of the manufacturer of the biological active substance | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Name and address of the manufacturer(s) responsible for batch release | Amgen NV Telecomlaan 5-7 1831 Diegem Belgium |
| Max shelf life | 5 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80 Sodium hydroxide (for pH-adjustment) |
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