INTELLIGENT OVERVIEW
Date: 18 September 2026
Regulatory Authority: European Medicines Agency (EMA)
Committee: Committee for Medicinal Products for Human Use (CHMP)
Product: Enhertu
Active Substance: Trastuzumab deruxtecan
Marketing Authorisation Holder: Daiichi Sankyo Europe GmbH
Therapeutic Area: Oncology – Breast Cancer
Regulatory Status: Positive CHMP Opinion
Regulatory Update
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 17 September 2026, recommending a change to the terms of the marketing authorisation for Enhertu (trastuzumab deruxtecan).
The recommended variation introduces a new indication for early breast cancer.
Under the proposed indication, Enhertu as monotherapy is recommended for the adjuvant treatment of adults with resected HER2-positive breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted treatment, subject to biomarker-based patient selection.
Key Regulatory Details
| Parameter | Details |
|---|---|
| Product | Enhertu |
| Active Substance | Trastuzumab deruxtecan |
| EMA Product Number | EMEA/H/C/005124 |
| MAH | Daiichi Sankyo Europe GmbH |
| Variation | Change to therapeutic indication |
| New Therapeutic Area | Early HER2-positive breast cancer |
| Treatment Setting | Adjuvant |
| CHMP Opinion | Positive |
| Opinion Date | 17 September 2026 |
| Current Status | Pending European Commission decision |
Regulatory Significance
The CHMP opinion represents another post-authorisation lifecycle development for Enhertu and expands its regulatory positioning into the adjuvant treatment setting for early HER2-positive breast cancer.
From a Regulatory Intelligence perspective, this update is relevant for monitoring:
- Product lifecycle management and indication expansion
- Changes to the EU marketing authorisation
- Evolution of Enhertu’s positioning across different breast cancer settings
- Potential implications for competitor products targeting HER2-positive breast cancer
- The subsequent European Commission decision and updated product information
EMA states that the updated Summary of Product Characteristics (SmPC) will be published after the European Commission grants the change to the marketing authorisation.
Source: https://www.ema.europa.eu/en/medicines/human/variation/enhertu-0