Enhertu

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trastuzumab deruxtecan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 17/11/2022

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 monitoringAdditional 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 approvalConditional 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
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
81379 Munich
Germany

Product information

10/11/2022 Enhertu - EMEA/H/C/005124 - IB/0026

Other EU languages available icon 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:

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.

Assessment history

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