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 used 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 together with chlorambucil (a cancer chemotherapy medicine) in patients for whom the cancer medicine fludarabine is not recommended;
  • follicular lymphoma (FL), another type of cancer of B-lymphocytes. Gazyvaro is used together with the chemotherapy medicine bendamustine in patients whose disease has not responded or whose cancer hasprogressed during or up to 6 months after treatment with the medicine rituximab. Following treatment with bendamustine Gazyvaro is then used on its own for the maintenance treatment of FL.

Gazyvaro contains the active substance obinutuzumab.

Because the number of patients with CLL and with FL is low, the diseases are considered ‘rare’, and Gazyvaro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 October 2012 and 19 June 2015.

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. As serious side effects including allergic reactions can develop treatment should be given in facilities where these reactions can be treated appropriately.

Gazyvaro is available as a concentrate that is made up into a solution for infusion (drip) into a vein and given over several hours. Treatment with Gazyvaro is given in six cycles and each cycle lasts 28 days.

For CLL, a dose of 100 mg of Gazyvaro is given on day one of the first cycle under close supervision of an experienced doctor who should monitor the patient for infusion-related reactions. A second dose of 900 mg can be given on the same day, if the patient does not have any reactions. In case of infusion-related reactions the second dose should be delayed until day 2. Further doses of 1,000 mg are then given on days 8 and 15 of the first cycle. For the remaining 5 cycles, Gazyvaro 1,000 mg is given on day one only.

For follicular lymphoma, Gazyvaro is given at a dose of 1,000 mg on day 1, 8 and 15 of the first 28-day treatment cycle. For the remaining 5 cycles, Gazyvaro 1,000 mg is given on day one only. Patients who respond to treatment, may continue to receive 1,000 mg Gazyvaro once every two months for two years or as long as they benefit from it.

Patients may also be given other medicines to prevent infusion-related reactions and other side effects. 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 B-lymphocytes. In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells are made) and in lymph nodes. By attaching to CD20 on B-lymphocytes, obinutuzumab makes the B-lymphocytes a target for the body’s immune (defence) system, which kills the B-lymphocytes.

What benefits of Gazyvaro have been shown in studies?

In CLL, Gazyvaro has been shown to significantly delay the disease 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). Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2 months).

Gazyvaro has also been investigated in a study involving 321 patients with follicular lymphoma in whom treatment with rituximab had either not worked or had stopped working. Patients treated with Gazyvaro and bendamustine lived significantly longer on average without their disease getting worse than patients treated with bendamustine alone (29.2 months versus 13.7 months).

What are the risks associated with Gazyvaro?

The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are upper respiratory infections (such as throad and nose infections), coughs, diarrhoea, constipation, joint pain, fever, weakness, neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts) and anaemia (low red blood cell counts). 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 European Union (EU). The CHMP considered that the benefit of Gazyvaro in prolonging the survival of CLL and FL patients before their disease worsened was clearly demonstrated. The pattern of side effects was considered acceptable in the light of the medicine’s benefit.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gazyvaro have been included in the summary of product characteristics and the package leaflet.

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 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public ES = español 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public CS = čeština 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public DA = dansk 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public DE = Deutsch 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public ET = eesti keel 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public EL = elliniká 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public FR = français 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public IT = italiano 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public LV = latviešu valoda 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public LT = lietuvių kalba 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public HU = magyar 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public MT = Malti 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public NL = Nederlands 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public PL = polski 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public PT = português 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public RO = română 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public SK = slovenčina 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public SL = slovenščina 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public FI = suomi 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public SV = svenska 2014-08-20 2016-07-28
Gazyvaro : EPAR - Summary for the public HR = Hrvatski 2014-08-20 2016-07-28
Name Language First published Last updated
Gazyvaro : EPAR - Risk-management-plan summary (English only) 2014-08-20  

This EPAR was last updated on 28/07/2016 .

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

Revision3
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

13/06/2016  Gazyvaro -EMEA/H/C/002799 -II/0007

Name Language First published Last updated
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28
Gazyvaro : EPAR - Product Information EN = English 2014-08-20 2016-07-28

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

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Chronic Lymphocytic Leukaemia (CLL)

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 (see section 5.1).

Follicular Lymphoma (FL)

Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

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 2015-08-17 2016-07-28
Gazyvaro-H-C-2799-II-0007 : EPAR - Assessment Report - Variation EN = English 2016-07-28  

Initial marketing-authorisation documents

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