Kyprolis

carfilzomib

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This is a summary of the European public assessment report (EPAR) for Kyprolis. 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 Kyprolis.

For practical information about using Kyprolis, patients should read the package leaflet or contact their doctor or pharmacist.

What is Kyprolis and what is it used for?

Kyprolis is a cancer medicine used in combination with two other medicines, lenalidomide and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least one previous treatment for their cancer.

Kyprolis contains the active substance carfilzomib. Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Kyprolis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 June 2008.

How is Kyprolis used?

Kyprolis can only be obtained with a prescription and treatment must be supervised by a doctor experienced in the treatment of cancer.

Kyprolis is available as a powder to be made up into a solution for infusion (drip) into a vein. It is given in four-week treatment cycles, on days 1, 2, 8, 9, 15 and 16 of each cycle. The starting dose is 20 mg per square metre of body surface area (calculated using the patient’s height and weight), which may be increased if the medicine is well tolerated. Each infusion should last 10 minutes. Treatment may need to be stopped or the dose reduced, if the disease gets worse or the patient experiences severe side effects.

How does Kyprolis work?

The active substance in Kyprolis, carfilzomib, is a proteasome inhibitor. This means that it blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed. Cancer cells have an increased need to produce and break down proteins due to the fact that they are multiplying rapidly. When proteins in the cancer cells are not broken down by the proteasome, they accumulate in the cells which eventually die, slowing down the growth of the cancer.

What benefits of Kyprolis have been shown in studies?

Kyprolis has been investigated in one main study involving 792 patients with multiple myeloma whose disease had got worse after previous treatment. In the study, Kyprolis taken in combination with lenalidomide and dexamethasone was compared with lenalidomide and dexamethasone. The study showed that Kyprolis is effective at prolonging the average length of time before the patient’s disease got worse again (progression-free survival): patients taking Kyprolis lived for an average of 26.3 months without their disease getting worse, compared with 17.6 months in the patients receiving only lenalidomide and dexamethasone.

What are the risks associated with Kyprolis?

The most common side effects with Kyprolis (which may affect more than 1 in 5 people) are anaemia (low red blood cell counts), tiredness, diarrhoea, thrombocytopenia (low blood platelet counts), nausea (feeling sick), fever, dyspnoea (difficulty breathing), respiratory tract (airways) infection, cough and peripheral oedema (swelling, especially of the ankles and feet).

The most serious side effects include toxic effects on the heart, lungs and liver, hypertension (high blood pressure), pulmonary hypertension (high blood pressure in the blood vessels in the lungs), dyspnoea, acute kidney failure, tumour lysis syndrome (a complication due to the breakdown of cancer cells), infusion reactions, thrombocytopenia, PRES (a reversible brain disorder) and TTP/HUS (diseases characterised by problems with the blood clotting system). For the full list of all side effects reported with Kyprolis, see the package leaflet.

Kyprolis must not be used in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

Why is Kyprolis approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Kyprolis’ benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted the unmet medical need for patients with multiple myeloma who no longer respond to the available therapies. It considered that the increase in time without the disease getting worse seen with Kyprolis was clinically meaningful. Although side effects, including severe effects, occur more frequently when Kyprolis is added to lenalidomide and dexamethasone treatment, these were considered acceptable and manageable.

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

A risk management plan has been developed to ensure that Kyprolis 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 Kyprolis, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Kyprolis

The European Commission granted a marketing authorisation valid throughout the European Union for Kyprolis on 19 November 2015.

For more information about treatment with Kyprolis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Kyprolis : EPAR - Summary for the public BG = bălgarski 01/12/2015  
Kyprolis : EPAR - Summary for the public ES = español 01/12/2015  
Kyprolis : EPAR - Summary for the public CS = čeština 01/12/2015  
Kyprolis : EPAR - Summary for the public DA = dansk 01/12/2015  
Kyprolis : EPAR - Summary for the public DE = Deutsch 01/12/2015  
Kyprolis : EPAR - Summary for the public ET = eesti keel 01/12/2015  
Kyprolis : EPAR - Summary for the public EL = elliniká 01/12/2015  
Kyprolis : EPAR - Summary for the public EN = English 01/12/2015  
Kyprolis : EPAR - Summary for the public FR = français 01/12/2015  
Kyprolis : EPAR - Summary for the public IT = italiano 01/12/2015  
Kyprolis : EPAR - Summary for the public LV = latviešu valoda 01/12/2015  
Kyprolis : EPAR - Summary for the public LT = lietuvių kalba 01/12/2015  
Kyprolis : EPAR - Summary for the public HU = magyar 01/12/2015  
Kyprolis : EPAR - Summary for the public MT = Malti 01/12/2015  
Kyprolis : EPAR - Summary for the public NL = Nederlands 01/12/2015  
Kyprolis : EPAR - Summary for the public PL = polski 01/12/2015  
Kyprolis : EPAR - Summary for the public PT = português 01/12/2015  
Kyprolis : EPAR - Summary for the public RO = română 01/12/2015  
Kyprolis : EPAR - Summary for the public SK = slovenčina 01/12/2015  
Kyprolis : EPAR - Summary for the public SL = slovenščina 01/12/2015  
Kyprolis : EPAR - Summary for the public FI = suomi 01/12/2015  
Kyprolis : EPAR - Summary for the public SV = svenska 01/12/2015  
Kyprolis : EPAR - Summary for the public HR = Hrvatski 01/12/2015  
Name Language First published Last updated
Kyprolis : EPAR - Risk-management-plan summary (English only) 01/12/2015  

This EPAR was last updated on 26/05/2016 .

Authorisation details

Product details

Product details for Kyprolis
NameKyprolis
Agency product numberEMEA/H/C/003790
Active substance

carfilzomib

International non-proprietary name (INN) or common name

carfilzomib

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XX45
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Kyprolis
Marketing-authorisation holder

Amgen Europe B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/11/2015

Contact address:

Amgen Europe B.V.
Minervum 7061 
Breda 4817ZK 
The Netherlands

Product information

Product information

28/04/2016  Kyprolis -EMEA/H/C/003790 -II/0004/G

Name Language First published Last updated
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016
Kyprolis : EPAR - Product Information EN = English 01/12/2015 26/05/2016

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
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  
Kyprolis : EPAR - All Authorised presentations EN = English 01/12/2015  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Kyprolis in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kyprolis : EPAR - Procedural steps taken and scientific information after authorisation EN = English 26/04/2016 26/05/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Kyprolis : EPAR - Public assessment report EN = English 01/12/2015  
CHMP summary of positive opinion Kyprolis EN = English 25/09/2015