🇪🇺 trastuzumab deruxtecan (T-DXd) in European Union

EMA authorised trastuzumab deruxtecan (T-DXd) on 18 January 2021

Marketing authorisation

EMA — authorised 18 January 2021

  • Application: EMEA/H/C/005124
  • Marketing authorisation holder: Daiichi Sankyo Europe GmbH
  • Local brand name: Enhertu
  • Indication: Breast cancerHER2-positive breast cancerEnhertu 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 cancerEnhertu 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
  • Pathway: conditional
  • Status: approved

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Other Oncology approved in European Union

Frequently asked questions

Is trastuzumab deruxtecan (T-DXd) approved in European Union?

Yes. EMA authorised it on 18 January 2021.

Who is the marketing authorisation holder for trastuzumab deruxtecan (T-DXd) in European Union?

Daiichi Sankyo Europe GmbH holds the EU marketing authorisation.