Trastuzumab emtansine

Therapeutic Trastuzumab emtansine antibody from the original Kadcyla® commercial drug.

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Antibody-drug conjugate (ADC)
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2 mg
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Kadcyla® / Tratuzumab Emtansine

Drug nameKadcyla®
INNTrastuzumab emtansine
API typeTrastuzumab 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 groupAntineoplastic agents, other antineoplastic agents, monoclonal
ATC codeL01XC14
Target of antibodyHER2
General functionTrastuzumab 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 numbersEU/1/13/885/001
Marketing authorisation holderRoche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Name of the manufacturer of the biological active substanceLonza Ltd.
CH-3930 Visp
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Whylen
Max shelf life3 years
Storage conditions2°C – 8°C
List of excipientsSuccinic acid
Sodium hydroxide
Polysorbate 20