Enhertu

RSS

trastuzumab deruxtecan

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

Overview

Enhertu is a medicine used for treating adults with:

  • HER2-positive breast cancer that is metastatic (has spread to other parts of the body) or cannot be removed by surgery. HER2-positive means that the cancer cells produce a protein called HER2 in large quantities on their surface, which makes the tumour cells grow more quickly. Enhertu is used on its own in patients who have received one or more HER2-targeted treatments;
  • HER2-low breast cancer that cannot be removed by surgery or is metastatic. HER2-low means that the cancer cells produce some HER2 on their surface, but less than HER2-positive cancer cells. Enhertu is used in patients who have previously received treatment after the disease had spread or whose disease came back during or within 6 months of treatment following surgery. It is used on its own in these patients;
  • advanced non-small cell lung cancer (NSCLC) whose cancer cells have a mutation (change) in the gene for the HER2 protein, called an activating HER2 mutation. It is used on its own in patients who had previously been treated with platinum-based chemotherapy with or without immunotherapy (treatment that boosts the immune system’s ability to fight the cancer);
  • HER2-positive advanced gastric cancer (cancer of the stomach) or gastro-oesophageal junction cancer (cancer at the junction between the stomach and the oesophagus). It is used on its own in patients who have previously received trastuzumab, another HER2-targeted treatment.

Enhertu contains the active substance trastuzumab deruxtecan.

This EPAR was last updated on 29/11/2023

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
L01FD04
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
13
Date of issue of marketing authorisation valid throughout the European Union
18/01/2021
Contact address

Zielstattstrasse 48
81379 Munich
Germany

Product information

18/10/2023 Enhertu - EMEA/H/C/005124 - II/0027

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

Breast cancer

HER2-positive breast cancer
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.

HER2-low breast cancer
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).

Non-small cell lung cancer (NSCLC)

Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Gastric cancer

Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

 

Assessment history

Changes since initial authorisation of medicine

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