Kadcyla

RSS

trastuzumab emtansine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 22/03/2023

Authorisation details

Product details
Name
Kadcyla
Agency product number
EMEA/H/C/002389
Active substance
trastuzumab emtansine
International non-proprietary name (INN) or common name
trastuzumab emtansine
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC14
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
15/11/2013
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

13/03/2023 Kadcyla - EMEA/H/C/002389 - N/0067

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

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