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.
Kadcyla : EPAR - Summary for the public (PDF/83.11 KB)
First published: 19/12/2013
Last updated: 26/04/2016
Kadcyla : EPAR - Risk management plan summary (PDF/117.33 KB)
First published: 27/08/2021
Last updated: 22/03/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
13/03/2023 Kadcyla - EMEA/H/C/002389 - N/0067
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.