European Commission approves Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer
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- 6 giorni fa
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The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
The approval introduces a new first-line HER2-directed regimen in the European Union based on results from the Phase III DESTINY-Breast09 trial.
Enhertu plus pertuzumab significantly reduced the risk of disease progression or death compared with the established taxane, trastuzumab and pertuzumab regimen, providing a new treatment option for eligible patients.
Field | Content |
Alert Type | Approval |
Drug Name | Trastuzumab deruxtecan plus pertuzumab |
Brand Name | Enhertu plus Perjeta |
Company | AstraZeneca; Daiichi Sankyo; Roche |
Regulatory Authority | European Commission |
Approval Type | Marketing authorisation / indication approval |
Indication | First-line treatment of adults with unresectable or metastatic HER2-positive breast cancer |
Therapy Area(s) | Oncology; breast cancer |
Geography | European Union |
What Happened | The European Commission approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. |
Why It Matters | The approval establishes a new first-line HER2-directed treatment option in the EU and represents the first major change to the treatment approach in this setting in more than a decade. |
Supporting Context | The approval was supported by results from the Phase III DESTINY-Breast09 trial comparing Enhertu plus pertuzumab with the established taxane, trastuzumab and pertuzumab regimen. |
Key Takeaway | European approval of Enhertu plus pertuzumab introduces a new first-line standard option for eligible adults with unresectable or metastatic HER2-positive breast cancer. |
What to Watch | Adoption of the combination across European markets and its impact on the sequencing of HER2-directed therapies in metastatic breast cancer. |
Primary Source | AstraZeneca |
Relevant Date | 1 September 2026 |
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