Therapeutic Trastuzumab Emtansine antibody from the original Kadcyla® commercial drug.
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Antibody-drug conjugate (ADC)
2-8°C / -80°C
|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|
|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.
(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.|
|Name and address of the manufacturer(s) responsible for batch release||Roche Pharma AG|
|Max shelf life||3 years|
|Storage conditions||2°C – 8°C|
|List of excipients||Succinic acid |
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