Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regime.
This is written in the approval document as:
Enhertu 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 line of treatment.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR somatic variants | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR p.T790M | Non-Small Cell Lung Cancer | Datopotamab deruxtecan | |
| Sensitivity (+) | EGFR Exon 20 (Insertion) | Invasive Breast Carcinoma | Datopotamab deruxtecan | |
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Datopotamab deruxtecan |