Gazyvaro

obinutuzumab

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

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

What is Gazyvaro and what is it used for?

Gazyvaro is a cancer medicine that contains the active substance obinutuzumab. It is used with chlorambucil (another cancer medicine) to treat adult patients with previously untreated chronic lymphocytic leukaemia (CLL). CLL is a cancer of B-lymphocytes, a type of white blood cells. Gazyvaro is used in patients with CLL who also have other medical conditions that make them ineligible for treatment based on a medicine called fludarabine.

Because the number of patients with CLL is low, the disease is considered ‘rare’, and Gazyvaro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 October 2012.

How is Gazyvaro used?

Gazyvaro can only be obtained with a prescription and treatment should be given under the close supervision of an experienced doctor. Treatment should be given in appropriate facilities in case serious side effects develop.

Gazyvaro is available as a concentrate that is made up into a solution for infusion (drip) into a vein over several hours. Treatment with Gazyvaro comprises six cycles and each cycle lasts 28 days. On day one of the first cycle, a dose of 100 mg is given as an infusion over four hours and under close supervision of a doctor, in case infusion-related reactions develop. A dose of 900 mg is given on day 2, but if no infusion-related reactions develop after the first dose, then it can be given on the same day. A dose of 1,000 mg is then given on days 8 and 15 of the first cycle. For the remaining 5 cycles, a dose of 1,000 mg is given on day one only. Patients will also be given other medicines to reduce the risk of developing infusion-related reactions and other side effects, as required. For further information, see the package leaflet.

How does Gazyvaro work?

The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD20, which is found on the surface of all B-lymphocytes. In CCL, cancerous B- lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells originate), and are unable to function properly. By attaching to CD20 on B-lymphocytes of patients with CLL, obinutuzumab causes the death of these abnormal lymphocytes.

The monoclonal antibody in Gazyvaro is produced using a method known as ‘recombinant DNA technology’. This means that it is made by cells into which a gene (DNA) has been introduced that makes them able to produce the antibody.

What benefits of Gazyvaro have been shown in studies?

Gazyvaro has been shown to significantly delay CLL getting worse in patients previously untreated who had other medical conditions and were therefore ineligible for fludarabine-based therapy. In one main study involving 781 patients, those treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with chlorambucil alone (26.7 months versus 11.1 months, respectively). Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer without their disease getting worse than patients treated with rituximab (another monoclonal antibody) and chlorambucil (an average of 26.7 months versus 15.2 months, respectively).

What are the risks associated with Gazyvaro?

The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are infusion-related reactions (such as fever, pain, chills and low blood pressure), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), diarrhoea and pyrexia (fever). Serious side effects included tumour lysis syndrome (a complication due to the breakdown of cancer cells), heart problems and, very rarely, progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death). For the full list of all side effects and restrictions, see the package leaflet.

Why is Gazyvaro approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Gazyvaro’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that the benefit of Gazyvaro in prolonging the survival of CLL patients before their disease worsened was clearly demonstrated. Regarding safety, the toxicity profile was considered acceptable in view of the extent of the benefit.

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

A risk management plan has been developed to ensure that Gazyvaro 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 Gazyvaro, 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 Gazyvaro

The European Commission granted a marketing authorisation valid throughout the European Union for Gazyvaro on 23 July 2014.

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

Name Language First published Last updated
Gazyvaro : EPAR - Summary for the public BG = bălgarski 20/08/2014  
Gazyvaro : EPAR - Summary for the public ES = español 20/08/2014  
Gazyvaro : EPAR - Summary for the public CS = čeština 20/08/2014  
Gazyvaro : EPAR - Summary for the public DA = dansk 20/08/2014  
Gazyvaro : EPAR - Summary for the public DE = Deutsch 20/08/2014  
Gazyvaro : EPAR - Summary for the public ET = eesti keel 20/08/2014  
Gazyvaro : EPAR - Summary for the public EL = elliniká 20/08/2014  
Gazyvaro : EPAR - Summary for the public EN = English 20/08/2014  
Gazyvaro : EPAR - Summary for the public FR = français 20/08/2014  
Gazyvaro : EPAR - Summary for the public IT = italiano 20/08/2014  
Gazyvaro : EPAR - Summary for the public LV = latviešu valoda 20/08/2014  
Gazyvaro : EPAR - Summary for the public LT = lietuvių kalba 20/08/2014  
Gazyvaro : EPAR - Summary for the public HU = magyar 20/08/2014  
Gazyvaro : EPAR - Summary for the public MT = Malti 20/08/2014  
Gazyvaro : EPAR - Summary for the public NL = Nederlands 20/08/2014  
Gazyvaro : EPAR - Summary for the public PL = polski 20/08/2014  
Gazyvaro : EPAR - Summary for the public PT = português 20/08/2014  
Gazyvaro : EPAR - Summary for the public RO = română 20/08/2014  
Gazyvaro : EPAR - Summary for the public SK = slovenčina 20/08/2014  
Gazyvaro : EPAR - Summary for the public SL = slovenščina 20/08/2014  
Gazyvaro : EPAR - Summary for the public FI = suomi 20/08/2014  
Gazyvaro : EPAR - Summary for the public SV = svenska 20/08/2014  
Gazyvaro : EPAR - Summary for the public HR = Hrvatski 20/08/2014  
Name Language First published Last updated
Gazyvaro : EPAR - Risk-management-plan summary (English only) 20/08/2014  

This EPAR was last updated on 29/04/2016 .

Authorisation details

Product details

Product details for Gazyvaro
NameGazyvaro
Agency product numberEMEA/H/C/002799
Active substance

obinutuzumab

International non-proprietary name (INN) or common name

obinutuzumab

Therapeutic area Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XC15
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 Gazyvaro
Marketing-authorisation holder

Roche Registration Ltd

Revision2
Date of issue of marketing authorisation valid throughout the European Union23/07/2014

Contact address:

Roche Registration Ltd
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom

Product information

Product information

01/04/2016  Gazyvaro -EMEA/H/C/002799 -II/0009

Name Language First published Last updated
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016
Gazyvaro : EPAR - Product Information EN = English 20/08/2014 29/04/2016

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
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  
Gazyvaro : EPAR - All Authorised presentations EN = English 20/08/2014  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Gazyvaro : EPAR - Procedural steps taken and scientific information after authorisation EN = English 17/08/2015 29/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Gazyvaro : EPAR - Public assessment report EN = English 20/08/2014  
CHMP summary of positive opinion for Gazyravo EN = English 23/05/2014