Chemical: Drug
trastuzumab emtansine
PharmGKB contains no prescribing info for this . Contact us to report known genotype-based dosing guidelines, or if you are interested in developing guidelines.
Annotated Labels
- Annotation of FDA Label for trastuzumab emtansine and ERBB2
- Annotation of EMA Label for trastuzumab emtansine and ERBB2
- Annotation of HCSC Label for trastuzumab emtansine and ERBB2
1. Annotation of FDA Label for trastuzumab emtansine and ERBB2
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.
2. Annotation of EMA Label for trastuzumab emtansine and ERBB2
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.
3. Annotation of HCSC Label for trastuzumab emtansine and ERBB2
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.
Overview
- T-DM1
- Trastuzumab-DM1
- Trastuzumab-MCC-DM1
- Trastuzumab-MCC-DM1 antibody-drug conjugate
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
- ATC: Monoclonal antibodies (L01XC)
- ATC: Combinations of antineoplastic agents (L01XY)
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 ?
Drug Targets
| Gene | Description |
|---|---|
| ERBB2 | [PMID: 21506905] (source: PharmGKB ) |
Curated Information ?
| Evidence | Disease |
|---|---|
| Breast Neoplasms |
Publications related to trastuzumab emtansine: 5
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EMA Initiatives and Perspectives on Pharmacogenomics. British journal of clinical pharmacology. 2014. Ehmann Falk, et al.
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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.
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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.
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Trastuzumab emtansine: a novel antibody-drug conjugate for HER2-positive breast cancer. Expert opinion on biological therapy. 2011. Burris Howard A.
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| HER2-amplified breast cancer: mechanisms of trastuzumab resistance and novel targeted therapies. Expert review of anticancer therapy. 2011. Gajria Devika, et al.
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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.
NURSA Datasets
No NURSA datasets available.