Drug
trastuzumab emtansine

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last updated 07/10/2014

European Medicines Agency (EMA) Label for trastuzumab emtansine and ERBB2

Genetic testing required

Summary

The EMA European Public Assessment Report (EPAR) for trastuzumab emtansine (Kadcyla) contains information regarding indication of the drug in patients with HER2-positive (encoded by the ERBB2 gene) breast cancer due to its mechanism of action, and HER2 positive status should be tested for by a validated method.

There's more of this label. Read more.



PharmGKB contains no Clinical Variants that meet the highest level of criteria.

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The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.

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2D structure from PubChem
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Overview

Generic Names
  • T-DM1
  • Trastuzumab-DM1
  • Trastuzumab-MCC-DM1
  • Trastuzumab-MCC-DM1 antibody-drug conjugate
Trade Names
Brand Mixture Names

PharmGKB Accession Id:
PA165958441
Type(s):
Drug

Description

Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate comprising trastuzumab and DM1, a microtubule polymerization inhibitor, covalently bound via a stable thioether linker [Article:22271209].

Source: PharmGKB

Indication

Trastuzumab emtansine is targeted toward HER2 (ERBB2) positive breast cancer, and has gone through phase I and II trials for patients with HER2-positive metastatic breast cancer [Article:21506905].

Source: PharmGKB

Other Vocabularies

Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.

Curated Information ?

EvidenceGene
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
CYP3A4
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
CYP3A5
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
ERBB2
No related drugs are available.

Curated Information ?

EvidenceDisease
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Breast Neoplasms

Publications related to trastuzumab emtansine: 1

No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Drug Interaction Potential of Trastuzumab Emtansine Combined With Pertuzumab in Patients With HER2-Positive Metastatic Breast Cancer. Current drug metabolism. 2012. Lu Dan, et al. PubMed

LinkOuts

PubChem Substance:
135353969
FDA Drug Label at DailyMed:
23f3c1f4-0fc8-4804-a9e3-04cf25dd302e

Clinical Trials

These are trials that mention trastuzumab emtansine and are related to either pharmacogenetics or pharmacogenomics.

No trials found.

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Sources for PharmGKB drug information: DrugBank, Open Eye Scientific Software.