Enhertu - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

trastuzumab deruxtecan

Opinion

On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Enhertu. The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH.

The CHMP adopted an extension to an existing indication to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer. The full indications for Enhertu will therefore be as follows:¹

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 and HER2-ultralow breast cancer

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic

• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).
• 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold

CHMP post-authorisation summary of positive opinion for Enhertu (II-48)

AdoptedReference Number: EMA/CHMP/67229/2025

Key facts

• Name of medicine:
  Enhertu
• EMA 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 therapeutical chemical (ATC) code:
  L01FD04
• 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.

• Marketing authorisation holder:
  Daiichi Sankyo Europe GmbH
• Date of opinion:
  27/02/2025
• Status:
  Positive