Darzalex

daratumumab

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

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

What is Darzalex and what is it used for?

Darzalex is a cancer medicine used on its own to treat adults with multiple myeloma (a cancer of the bone marrow). It is used when the disease has come back after treatment with cancer medicines (including medicines known as proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines.

Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Darzalex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2013.

Darzalex contains the active substance daratumumab.

How is Darzalex used?

Darzalex is available as a concentrate to be made into a solution for infusion (drip) into a vein. The recommended dose is 16 mg per kilogram body weight, which is given once a week for the first 8 weeks. From week 9 to week 24, Darzalex is given every 2 weeks, and then every 4 weeks. Treatment continues for as long as the patient benefits from it. Before and after the infusion, patients should receive medicines to reduce the risk of infusion-related reactions. The doctor may need to reduce the infusion rate or stop treatment in case of severe infusion-related reactions.

Darzalex can only be obtained with a prescription and should be given by a healthcare professional in a place where facilities for resuscitating patients are readily available. For further information, see the summary of product characteristics (also part of the EPAR).

How does Darzalex work?

The active substance in Darzalex, daratumumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, daratumumab activates the immune system to kill the cancer cells.

What benefits of Darzalex have been shown in studies?

Darzalex has been investigated in two main studies involving a total of 196 multiple myeloma patients whose disease came back after, or did not respond to, at least two previous treatments including a proteasome inhibitor and an immunomodulatory agent. The main measure of effectiveness was the proportion of patients who responded completely or partially to treatment (as measured by the disappearance of or at least a 50% reduction in a protein found in excess in multiple myeloma cells). Around 29% of the patients receiving Darzalex at a dose of 16 mg/kg (31 out of 106 patients) responded completely or partially to treatment in one study and 36% (15 out of 42 patients) in the second study. In these studies Darzalex was not compared with any other treatment.

What are the risks associated with Darzalex?

The most common side effects with Darzalex (which may affect around 1 in 2 people) are infusion-related reactions such as breathing problems, cough, runny or blocked nose and chills. Other frequent side effects (affecting at least 1 in 5 patients) are tiredness, pyrexia (fever), nausea (feeling sick), back pain, upper respiratory tract infections (such as colds), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell) and thrombocytopenia (low blood platelet counts). For the full list of all side effects and restrictions with Darzalex, see the package leaflet.

Why is Darzalex approved?

Darzalex has been shown to be effective at treating multiple myeloma in patients whose disease had progressed despite at least two previous treatments. These patients have limited treatment options and Darzalex, which works in a different way to existing treatments, represents an alternative. Darzalex’s safety profile is considered acceptable and manageable.

Although there were limitations in the studies, including lack of control group and low number of patients, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Darzalex’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Darzalex has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Darzalex?

Since Darzalex has been granted a conditional approval, the company that markets Darzalex will provide the results of two studies comparing the effect of Darzalex used in combination with other cancer treatments (i.e. lenalidomide and dexamethasone, or bortezomib and dexamethasone) with that of these other treatments given on their own.

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

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

In addition, the company that markets Darzalex will provide educational material to all healthcare professionals expected to use the medicine, to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions. Patients who are prescribed Darzalex will be provided with a patient alert card with similar information.

Other information about Darzalex

The European Commission granted a marketing authorisation valid throughout the European Union for Darzalex on 20 May 2016.

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

Name Language First published Last updated
Darzalex : EPAR - Summary for the public BG = bălgarski 2016-05-27  
Darzalex : EPAR - Summary for the public ES = español 2016-05-27  
Darzalex : EPAR - Summary for the public CS = čeština 2016-05-27  
Darzalex : EPAR - Summary for the public DA = dansk 2016-05-27  
Darzalex : EPAR - Summary for the public DE = Deutsch 2016-05-27  
Darzalex : EPAR - Summary for the public ET = eesti keel 2016-05-27  
Darzalex : EPAR - Summary for the public EL = elliniká 2016-05-27  
Darzalex : EPAR - Summary for the public EN = English 2016-05-27  
Darzalex : EPAR - Summary for the public FR = français 2016-05-27  
Darzalex : EPAR - Summary for the public IT = italiano 2016-05-27  
Darzalex : EPAR - Summary for the public LV = latviešu valoda 2016-05-27  
Darzalex : EPAR - Summary for the public LT = lietuvių kalba 2016-05-27  
Darzalex : EPAR - Summary for the public HU = magyar 2016-05-27  
Darzalex : EPAR - Summary for the public MT = Malti 2016-05-27  
Darzalex : EPAR - Summary for the public NL = Nederlands 2016-05-27  
Darzalex : EPAR - Summary for the public PL = polski 2016-05-27  
Darzalex : EPAR - Summary for the public PT = português 2016-05-27  
Darzalex : EPAR - Summary for the public RO = română 2016-05-27  
Darzalex : EPAR - Summary for the public SK = slovenčina 2016-05-27  
Darzalex : EPAR - Summary for the public SL = slovenščina 2016-05-27  
Darzalex : EPAR - Summary for the public FI = suomi 2016-05-27  
Darzalex : EPAR - Summary for the public SV = svenska 2016-05-27  
Darzalex : EPAR - Summary for the public HR = Hrvatski 2016-05-27  

This EPAR was last updated on 27/05/2016 .

Authorisation details

Product details

Product details for Darzalex
NameDarzalex
Agency product numberEMEA/H/C/004077
Active substance

daratumumab

International non-proprietary name (INN) or common name

daratumumab

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XC24
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.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Darzalex
Marketing-authorisation holder

Janssen-Cilag International N.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union20/05/2016

Contact address:

Janssen-Cilag International N.V.
Turnhoutseweg 30 
2340 Beerse 
Belgium

Product information

Product information

20/05/2016  Darzalex -EMEA/H/C/004077 --

Name Language First published Last updated
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  
Darzalex : EPAR - Product Information HR = Hrvatski 2016-05-27  

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
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Darzalex : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  

Pharmacotherapeutic group

Antineoplastic agents, monoclonal antibodies

Therapeutic indication

Darzalex as monotherapy is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Darzalex : EPAR - Public assessment report HR = Hrvatski 2016-05-27  
CHMP summary of opinion for Darzalex HR = Hrvatski 2016-04-01