Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimes.
This is written in the approval document as:
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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
Type | Biomarker(s) | Cancer type | Therapy(ies) | |
---|---|---|---|---|
Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Trastuzumab deruxtecan | |
Sensitivity (+) | ERBB2 amplification | Invasive Breast Carcinoma | Trastuzumab deruxtecan |