This is a summary of the European public assessment report (EPAR) for Kadcyla. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kadcyla. For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication **Early Breast Cancer (EBC)** Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. **Metastatic Breast Cancer (MBC)** 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.
Therapeutic Area (MeSH)
N/AATC Code
L01XC14
ATC Item
xl 01 xc 14
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| trastuzumab emtansine | N/A | 恩美曲妥珠单抗 |
EMA Name
Kadcyla
Medicine Name
Kadcyla
Aliases
N/ANo risk management plan link.
