Enhertu
trastuzumab deruxtecan
Table of contents
Overview
Enhertu is a medicine used to treat breast cancer that is metastatic (has spread to other parts of the body) or cannot be removed by surgery.
It can only be used when the cancer has been shown to ‘overexpress HER2’: this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Enhertu is used on its own in patients who have received two or more HER2-targeted treatments.
It contains the active substance trastuzumab deruxtecan.
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Enhertu : EPAR - Medicine overview (PDF/178.36 KB)
First published: 08/02/2021
EMA/692819/2020 -
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Enhertu : EPAR - Risk-management-plan summary (PDF/408.23 KB)
First published: 08/02/2021
Last updated: 01/08/2022
Authorisation details
Product details | |
---|---|
Name |
Enhertu
|
Agency product number |
EMEA/H/C/005124
|
Active substance |
trastuzumab deruxtecan
|
International non-proprietary name (INN) or common name |
trastuzumab deruxtecan
|
Therapeutic area (MeSH) |
Breast Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01XC
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
Daiichi Sankyo Europe GmbH
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
18/01/2021
|
Contact address |
Zielstattstrasse 48 |
Product information
10/11/2022 Enhertu - EMEA/H/C/005124 - IB/0026
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens.