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Therapeutic Teclistamab antibody from the original Tecvayli® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
B cell maturation antigen , CD3 |
Bispecific Antibody |
Tecvayli® |
10 mg/mL |
– |
1 mg |
-80°C |
2024.10 |
410,00 € |
| Drug name | Tecvayli® |
| INN | Teclistamab |
| API type | Bispecific antibody directed against the B cell maturation antigen (BCMA) and CD3 receptors, produced in a mammalian cell line (Chinese hamster ovary [CHO]) using recombinant DNA technology |
| Pharmacotherapeutic group | Other monoclonal antibodies and antibody drug conjugates |
| ATC code | L01FX24 |
| Target of antibody | CD3 receptor expressed on the surface of T cells, B cell maturation antigen (BCMA) expressed on the surface of malignant multiple myeloma B-lineage cells |
| General function | Teclistamab is able to draw CD3+ T cells in close proximity to BCMA+ cells, resulting in T cell activation and subsequent lysis and death of BCMA+ cells, which is mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. This effect occurs without regard to T cell receptor specificity or reliance on major histocompatibility complex (MHC) Class 1 molecules on the surface of antigen presenting cells. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Teclistamab is a full-size, IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Within the first month of treatment, activation of T-cells, redistribution of T-cells, reduction of B-cells and induction of serum cytokines were observed. 18Within one month of treatment with teclistamab, the majority of responders had reduction in soluble BCMA, and a greater reduction in soluble BCMA was observed in subjects with deeper responses to teclistamab. |
| Original license holder | Janssen-Cilag International N.V. Turnhoutseweg 30 Beerse 2340 Antwerp Belgium |
| Marketing authorisation numbers | EU/1/22/1675/001 (10 mg/ml) EU/1/22/1675/002 (90 mg/ml) |
| Marketing authorisation holder | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Name of the manufacturer of the biological active substance | Janssen Sciences Ireland UC Barnahely, Ringaskiddy, Co. Cork Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Janssen Biologics B.V. Einsteinweg 101 2333 CB Leiden The Netherlands Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | EDTA disodium salt dihydrate Glacial acetic acid Polysorbate 20 (E432) Sodium acetate trihydrate Sucrose Water for injections |
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