Mvasi

bevacizumab

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

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

What is Mvasi and what is it used for?

Mvasi is a cancer medicine that is used to treat adults with the following cancers:

  • cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
  • breast cancer that has spread to other parts of the body;
  • a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery, including cases where the cancer cells have a mutation (change) in the gene for a protein called EGFR. Mvasi can be used in non-small cell lung cancer unless it orginates in cells of a particular type (called squamous cells);
  • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
  • cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
  • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.

Mvasi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect its sensitivity to particular medicines.

Mvasi contains the active substance bevacizumab and is a ‘biosimilar medicine’. This means that Mvasi is similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Mvasi is Avastin.

How is Mvasi used?

Mvasi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.

Mvasi is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The first infusion of Mvasi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well. The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used. The treatment is continued until the patient no longer benefits from it. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.

For further information, see the package leaflet.

How does Mvasi work?

The active substance in Mvasi, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow. By attaching to VEGF, Mvasi stops it having an effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.

What benefits of Mvasi have been shown in studies?

Laboratory studies comparing Mvasi with Avastin have shown that the active substance in Mvasi is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.

In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel. The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).

Because Mvasi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Mvasi.

What are the risks associated with Mvasi?

The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Mvasi, see the package leaflet.

Mvasi must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies. It must not be given to pregnant women.

Why is Mvasi approved?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Mvasi has been shown to have a comparable quality, safety and effectiveness to Avastin.

Therefore, the Agency’s view was that, as for Avastin, the benefit outweighs the identified risk. The Agency recommended that Mvasi be given marketing authorisation.

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

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

Other information about Mvasi

The European Commission granted a marketing authorisation valid throughout the European Union for Mvasi on 15 January 2018.

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

Name Language First published Last updated
Mvasi : EPAR - Summary for the public BG = bălgarski 2018-01-31  
Mvasi : EPAR - Summary for the public ES = español 2018-01-31  
Mvasi : EPAR - Summary for the public CS = čeština 2018-01-31  
Mvasi : EPAR - Summary for the public DA = dansk 2018-01-31  
Mvasi : EPAR - Summary for the public DE = Deutsch 2018-01-31  
Mvasi : EPAR - Summary for the public ET = eesti keel 2018-01-31  
Mvasi : EPAR - Summary for the public EL = elliniká 2018-01-31  
Mvasi : EPAR - Summary for the public EN = English 2018-01-31  
Mvasi : EPAR - Summary for the public FR = français 2018-01-31  
Mvasi : EPAR - Summary for the public IT = italiano 2018-01-31  
Mvasi : EPAR - Summary for the public LV = latviešu valoda 2018-01-31  
Mvasi : EPAR - Summary for the public LT = lietuvių kalba 2018-01-31  
Mvasi : EPAR - Summary for the public HU = magyar 2018-01-31  
Mvasi : EPAR - Summary for the public MT = Malti 2018-01-31  
Mvasi : EPAR - Summary for the public NL = Nederlands 2018-01-31  
Mvasi : EPAR - Summary for the public PL = polski 2018-01-31  
Mvasi : EPAR - Summary for the public PT = português 2018-01-31  
Mvasi : EPAR - Summary for the public RO = română 2018-01-31  
Mvasi : EPAR - Summary for the public SK = slovenčina 2018-01-31  
Mvasi : EPAR - Summary for the public SL = slovenščina 2018-01-31  
Mvasi : EPAR - Summary for the public FI = suomi 2018-01-31  
Mvasi : EPAR - Summary for the public SV = svenska 2018-01-31  
Mvasi : EPAR - Summary for the public HR = Hrvatski 2018-01-31  

This EPAR was last updated on 15/03/2018 .

Authorisation details

Product details

Product details for Mvasi
NameMvasi
Agency product numberEMEA/H/C/004728
Active substance

bevacizumab

International non-proprietary name (INN) or common name

bevacizumab

Therapeutic area Fallopian Tube NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellOvarian NeoplasmsPeritoneal NeoplasmsBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XC07
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.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Mvasi
Marketing-authorisation holder

Amgen Europe B.V.

Revision1
Date of issue of marketing authorisation valid throughout the European Union15/01/2018

Contact address:

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

Product information

Product information

12/02/2018  Mvasi -EMEA/H/C/004728 -IAIN/0001

Name Language First published Last updated
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15
Mvasi : EPAR - Product Information HR = Hrvatski 2018-01-31 2018-03-15

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
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  
Mvasi : EPAR - All Authorised presentations HR = Hrvatski 2018-01-31  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status.

Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Mvasi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Mvasi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2018-03-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Mvasi : EPAR - Public assessment report HR = Hrvatski 2018-01-31  
CHMP summary of positive opinion for Mvasi HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union

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