Chemical: Drug
trastuzumab emtansine

PharmGKB contains no dosing guidelines for this . To report known genotype-based dosing guidelines, or if you are interested in developing guidelines, click here.


Annotated Labels

  1. FDA Label for trastuzumab emtansine and ERBB2
  2. EMA Label for trastuzumab emtansine and ERBB2
  3. HCSC Label for trastuzumab emtansine and ERBB2

last updated 10/25/2013

1. FDA Label for trastuzumab emtansine and ERBB2

Genetic testing required

Summary

The FDA-approved label requires test results demonstrating HER2 protein overexpression prior to initiating therapy with trastuzumab emtansine using FDA-approved tests by laboratories with demonstrated proficiency.

There's more of this label. Read more.


last updated 07/10/2014

2. 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.


last updated 06/08/2015

3. HCSC Label for trastuzumab emtansine and ERBB2

Genetic testing required

Summary

The product monograph for trastuzumab emtansine (KADCYLA) states that it is indicated for patients with HER2-positive, metastatic breast cancer who received prior treatment with trastuzumab and a taxane, separately or in combination.

There's more of this label. Read more.


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

Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.

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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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
ERBB2

Drug Targets

Gene Description
ERBB2 [PMID: 21506905] (source: PharmGKB)
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: 5

No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
EMA Initiatives and Perspectives on Pharmacogenomics. British journal of clinical pharmacology. 2014. Ehmann Falk, et al. PubMed
No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer chemotherapy and pharmacology. 2012. Girish Sandhya, et al. PubMed
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
No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Trastuzumab emtansine: a novel antibody-drug conjugate for HER2-positive breast cancer. Expert opinion on biological therapy. 2011. Burris Howard A. PubMed
No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available VIP No VIP available
HER2-amplified breast cancer: mechanisms of trastuzumab resistance and novel targeted therapies. Expert review of anticancer therapy. 2011. Gajria Devika, 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.

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NURSA Datasets

provided by nursa.org

No NURSA datasets available.

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Sources for PharmGKB drug information: DrugBank, PubChem.