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
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Roche Registration GmbH
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16/09/2018 Kadcyla - EMEA/H/C/002389 - R/0039
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.