European Commission approves Enhertu for residual HER2-positive early breast cancer after neoadjuvant therapy
The European Commission has approved Enhertu for patients with residual HER2-positive early breast cancer, extending the antibody-drug conjugate into a curative-intent treatment setting.
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) is now authorised as adjuvant therapy for adults with resected HER2-positive early breast cancer who have residual invasive disease following neoadjuvant taxane-based chemotherapy and HER2-targeted treatment.
The approval is supported by Phase III DESTINY-Breast05 results showing a 53% reduction in the risk of invasive disease recurrence or death compared with trastuzumab emtansine, establishing Enhertu's first European authorisation in the early breast cancer setting.
Field | Content |
Article Type | Approvals |
Companies | AstraZeneca; Daiichi Sankyo |
Product | Enhertu |
Generic Name | Trastuzumab deruxtecan |
Modality | HER2-directed antibody-drug conjugate |
Regulator | European Commission |
Approval Type | Marketing authorisation for an additional indication |
Approval Announcement Date | 27 October 2026 |
Indication | Adjuvant treatment of HER2-positive early breast cancer with residual invasive disease following neoadjuvant therapy |
Patient Population | Adults with resected HER2-positive early breast cancer and residual invasive disease |
Disease Setting | Early breast cancer; postoperative adjuvant treatment |
Prior Treatment Requirement | Neoadjuvant taxane-based chemotherapy and HER2-targeted therapy |
Treatment Intent | Curative intent |
Biomarker | HER2-positive |
Clinical Study | DESTINY-Breast05 |
Study Phase | Phase III |
Comparator | Trastuzumab emtansine (T-DM1) |
Primary Reported Outcome | 53% reduction in the risk of invasive disease recurrence or death compared with T-DM1 |
Clinical Endpoint | Invasive disease-free survival |
Geographic Scope | European Union |
Previous Treatment Settings | Previously authorised advanced breast cancer indications |
Regulatory Significance | First EU approval of Enhertu in early breast cancer |
What Happened | The European Commission authorised Enhertu for adjuvant treatment of eligible adults with residual HER2-positive early breast cancer. |
Why It Matters | The approval moves a HER2-directed antibody-drug conjugate into an earlier treatment setting where preventing invasive recurrence is a central clinical objective. |
Clinical Evidence | DESTINY-Breast05 demonstrated a 53% relative reduction in invasive recurrence or death versus T-DM1. |
Key Takeaway | Enhertu has entered the European early breast cancer treatment pathway for patients with residual invasive disease after neoadjuvant therapy. |
What to Watch | European clinical guideline updates, reimbursement decisions, treatment adoption, long-term survival data and safety monitoring. |
Primary Source | AstraZeneca |
Primary Source URL | https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-approved-eu-for-her2-positive-ebc.html |
Relevant Date | 27 October 2026 |
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