Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized trastuzumab emtansine for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in cobmination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
This is written in the approval document as:
Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
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 emtansine | |
| Sensitivity (+) | ERBB2 amplification | Invasive Breast Carcinoma | Trastuzumab emtansine |