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Therapeutic Trastuzumab emtansine antibody from the original Kadcyla® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
HER2 |
Antibody-drug conjugate (ADC) |
Kadcyla® |
20 mg/mL |
– |
2 mg |
-80°C |
07/2023 |
348,30 € |
| Drug name | Kadcyla® | |||
| INN | Trastuzumab emtansine | |||
| API type | Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate) | |||
| Pharmacotherapeutic group | Antineoplastic agents, other antineoplastic agents, monoclonal | |||
| ATC code | L01XC14 | |||
| Target of antibody | HER2 | |||
| General function | Trastuzumab emtansine, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Is also indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. | |||
| Short description | ||||
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Trastuzumab emtansine, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). Emtansine refers to the MCC-DM1 complex. An average of 3.5 DM1 molecules are conjugated to each molecule of trastuzumab. | |||
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | The population pharmacokinetic analysis suggested no difference in trastuzumab emtansine exposure based on disease status (adjuvant vs. metastatic setting) | |||
| Original license holder | ||||
| Marketing authorisation numbers | EU/1/13/885/001 | |||
| Marketing authorisation holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany | |||
| Name of the manufacturer of the biological active substance | Lonza Ltd. Lonzastrasse CH-3930 Visp Switzerland | |||
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Germany | |||
| Max shelf life | 3 years | |||
| Storage conditions | 2°C – 8°C | |||
| List of excipients | Succinic acid Sodium hydroxide Sucrose Polysorbate 20 |
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