Kadcyla

trastuzumab emtansine

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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.

What is Kadcyla and what is it used for?

Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine. It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).

Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2’: this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).

How is Kadcyla used?

Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.

Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein. The dose to be given depends on the patient’s bodyweight and the infusion is repeated every 3 weeks. Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes. Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.

Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever. In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.

For further information, see the package leaflet.

How does Kadcyla work?

The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:

  • Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells. Trastuzumab also stops HER2 from stimulating the growth of the cancer cells. About a quarter of breast cancers overexpress HER2.
  • DM1, a toxic substance that kills cells when they attempt to divide and grow. DM1 becomes active once Kadcyla enters the cancer cell. It attaches to a protein in cells called ‘tubulin’, which is important in the formation of the internal ‘skeleton’ that cells need to assemble when they divide. By attaching to tubulin in cancer cells, DM1 stops the formation of this skeleton, preventing the division and growth of the cancer cells.
What benefits of Kadcyla have been shown in studies?

Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane. In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib. Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.

What are the risks associated with Kadcyla?

The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache. The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.

For the full list of all side effects reported with Kadcyla, see the package leaflet.

Why is Kadcyla approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy. Regarding Kadcyla’s safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.

What measures are being taken to ensure the safe and effective use of Kadcyla?

A risk management plan has been developed to ensure that Kadcyla is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.

Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.

Other information about Kadcyla

The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15 November 2013.

Name Language First published Last updated
Kadcyla : EPAR - Summary for the public BG = bălgarski 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public ES = español 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public CS = čeština 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public DA = dansk 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public DE = Deutsch 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public ET = eesti keel 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public EL = elliniká 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public EN = English 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public FR = français 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public IT = italiano 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public LV = latviešu valoda 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public LT = lietuvių kalba 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public HU = magyar 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public MT = Malti 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public NL = Nederlands 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public PL = polski 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public PT = português 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public RO = română 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public SK = slovenčina 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public SL = slovenščina 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public FI = suomi 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public SV = svenska 19/12/2013 26/04/2016
Kadcyla : EPAR - Summary for the public HR = Hrvatski 19/12/2013 26/04/2016

This EPAR was last updated on 19/05/2016 .

Authorisation details

Product details

Product details for Kadcyla
NameKadcyla
Agency product numberEMEA/H/C/002389
Active substance

trastuzumab emtansine

International non-proprietary name (INN) or common name

trastuzumab emtansine

Therapeutic area Breast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XC14
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Kadcyla
Marketing-authorisation holder

Roche Registration Ltd

Revision5
Date of issue of marketing authorisation valid throughout the European Union15/11/2013

Contact address:

Roche Registration Ltd
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 3AY
United Kingdom

Product information

Product information

04/05/2016  Kadcyla -EMEA/H/C/002389 -N/0024

Name Language First published Last updated
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016
Kadcyla : EPAR - Product Information HR = Hrvatski 19/12/2013 19/05/2016

Contents

  • 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.


Name Language First published Last updated
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  
Kadcyla : EPAR - All Authorised presentations HR = Hrvatski 19/12/2013  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Kadcyla : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 03/12/2014 19/05/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Kadcyla : EPAR - Public assessment report HR = Hrvatski 19/12/2013  
CHMP summary of positive opinion for Kadcyla HR = Hrvatski 20/09/2013  

Authorised

This medicine is approved for use in the European Union