Difference between revisions of "Trastuzumab emtansine (Kadcyla)"

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==Diseases for which it is used==
 
==Diseases for which it is used==
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*[[Breast cancer]]
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*[[Breast_cancer,_HER-2_positive|HER2+ breast cancer]]
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==Clinical trials==
 
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*[http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84883 EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.]<ref>S. Verma, V. Dieras, L. Gianni, D. Miles, M. Welslau, M. D. Pegram, J. Baselga, E. Guardino, L. Fang, C. M. Linehan, K. L. Blackwell. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84883 EMILIA: A phase III, randomized, multicenter study of trastuzumab-DM1 (T-DM1) compared with lapatinib (L) plus capecitabine (X) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) and previously treated with a trastuzumab-based regimen.] 2011 ASCO Annual Meeting abstract TPS116.</ref><ref>[http://clinicaltrials.gov/ct2/show/NCT00829166 EMILIA at ClinicalTrials.gov]</ref>
 
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*[http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84827 MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC).]<ref>P. A. Ellis, C. H. Barrios, Y. Im, M. Patre, F. Branle, E. A. Perez. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=84827 MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC).] 2011 ASCO Annual Meeting abstract TPS102.</ref><ref>[http://clinicaltrials.gov/ct2/show/NCT01120184 MARIANNE at ClinicialTrials.gov]</ref>
 
  
 
==Patient drug information==
 
==Patient drug information==
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==Also known as==
 
==Also known as==
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PRO132365, TDM1, T-DM1, trastuzumab emtansine.
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*'''Code name:''' PRO132365
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*'''Generic names:''' TDM1, T-DM1, trastuzumab emtansine
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*'''Brand name:''' Kadcyla
  
 
==References==
 
==References==
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[[Category:Drug index]]
 
[[Category:Drug index]]
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[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 
[[Category:Irritant chemotherapy]]
 
[[Category:Irritant chemotherapy]]
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[[Category:Antibody medications]]
 
[[Category:Antibody medications]]
 
[[Category:Antibody-drug conjugates]]
 
[[Category:Antibody-drug conjugates]]
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[[Category:Anti-HER2 medications]]
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[[Category:Anti-HER2 antibodies]]
 
[[Category:Microtubule inhibitors]]
 
[[Category:Microtubule inhibitors]]
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[[Category:Protein expression-specific medications]]
  
 
[[Category:Breast cancer medications]]
 
[[Category:Breast cancer medications]]
 
[[Category:Drugs FDA approved in 2013]]
 
[[Category:Drugs FDA approved in 2013]]

Revision as of 00:06, 27 October 2017

General information

Class/mechanism: Antibody-cytotoxic agent conjugate consisting of the HER2 humanized IgG1 kappa monoclonal antibody Trastuzumab (Herceptin) linked with a small molecule microtubule inhibitor and maytansine derivative, emtansine (DM1). The humanized monoclonal antibody binds to subdomain IV of the HER2 receptor, is subjected to receptor-mediated endocytosis, and lysosomal degradation leads to the intracellular release of DM1. DM1 binds to tubulin at the rhizoxin binding site, inhibits the assembly of microtubules, and leads to cell cycle arrest and cell death via apoptosis. Similar to Trastuzumab (Herceptin), ado-trastuzumab emtansine inhibits HER2 receptor signaling, facilitates antibody-dependent cell-mediated cytotoxicity (ADCC), and inhibits shedding of the HER2 extracellular domain in HER2-overexpressing human breast cancer cells.[1][2][3][4][5][6]
Route: IV
Extravasation: irritant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Also known as

  • Code name: PRO132365
  • Generic names: TDM1, T-DM1, trastuzumab emtansine
  • Brand name: Kadcyla

References

  1. ↑ 1.0 1.1 1.2 Ado-trastuzumab emtansine (Kadcyla) package insert
  2. ↑ Ado-trastuzumab emtansine (Kadcyla) package insert (locally hosted backup)
  3. ↑ Kadcyla manufacturer's website
  4. ↑ ImmunoGen product site
  5. ↑ http://www.immunogen.com/img/T-DM1%20+%20pertuzumab%20at%20SABCS.pdf A Phase Ib/II Trial of Trastuzumab-DM1 (T-DM1) with Pertuzumab for Patients with HER2-Positive, Locally Advanced or Metastatic Breast Cancer: Interim Efficacy and Safety Results
  6. ↑ Dr. Sara Hurvitz's 2011 European Society for Medical Oncology (ESMO) Presentation
  7. ↑ Ado-trastuzumab emtansine (Kadcyla) patient drug information (Chemocare)
  8. ↑ Ado-trastuzumab emtansine (Kadcyla) patient drug information (UpToDate)
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