Bavencio

avelumab

  • Email
  • Help

About

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

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

What is Bavencio and what is it used for?

Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.

Because the number of patients with MCC is low, the disease is considered ‘rare’, and Bavencio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 December 2015.

Bavencio contains the active substance avelumab.

How is Bavencio used?

Bavencio can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the treatment of cancer.

Bavencio is given as an infusion (drip) into a vein lasting around 1 hour, once every 2 weeks. The dose depends on body weight. Treatment should continue as long as the patient benefits from it or side effects become unacceptable.

Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing. If no reactions have occurred by the fourth infusion, the treating doctor may decide to stop giving these medicines before subsequent infusions.

How does Bavencio work?

The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1’ (PD-L1), which is present on the surface of many cancer cells. PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells. By attaching to PD-L1, Bavencio prevents the cancer cells from switching off the T cells, thereby increasing the ability of the T cells to kill the cancer cells.

What benefits of Bavencio have been shown in studies?

Bavencio can reduce tumour size in some patients, leading to either partial responses or complete response (when no signs of the cancer remain).

In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a complete or partial response to the medicine; in most of these patients, the response lasted for at least 6 months.

Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the complete or partial response rate at the time of analysis was 62% (18 out of 29 patients).

What are the risks associated with Bavencio?

The most common side effects with Bavencio (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting. Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.

For the full list of all side effects and restrictions with Bavencio, see the package leaflet.

Why is Bavencio approved?

Patients with MCC that has spread and come back after initial treatment with chemotherapy have very limited treatment options. Although the response rates to Bavencio are not outstanding, the duration of the response (at least 6 months) is important for these patients, since the responses seen with chemotherapy medicines are of shorter duration. In addition, early data from an ongoing study indicate that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response. The safety of Bavencio is considered acceptable and side effects manageable with the additional measures put in place.

The European Medicines Agency therefore decided that Bavencio’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Bavencio 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 Bavencio?

Since Bavencio has been granted a conditional approval, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.

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

The company that markets Bavencio will issue educational materials for healthcare professionals and patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.

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

Other information about Bavencio

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Bavencio on 18 September 2017.

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

Name Language First published Last updated
Bavencio : EPAR - Summary for the public BG = bălgarski 2017-10-13  
Bavencio : EPAR - Summary for the public ES = español 2017-10-13  
Bavencio : EPAR - Summary for the public CS = čeština 2017-10-13  
Bavencio : EPAR - Summary for the public DA = dansk 2017-10-13  
Bavencio : EPAR - Summary for the public DE = Deutsch 2017-10-13  
Bavencio : EPAR - Summary for the public ET = eesti keel 2017-10-13  
Bavencio : EPAR - Summary for the public EL = elliniká 2017-10-13  
Bavencio : EPAR - Summary for the public EN = English 2017-10-13  
Bavencio : EPAR - Summary for the public FR = français 2017-10-13  
Bavencio : EPAR - Summary for the public IT = italiano 2017-10-13  
Bavencio : EPAR - Summary for the public LV = latviešu valoda 2017-10-13  
Bavencio : EPAR - Summary for the public LT = lietuvių kalba 2017-10-13  
Bavencio : EPAR - Summary for the public HU = magyar 2017-10-13  
Bavencio : EPAR - Summary for the public MT = Malti 2017-10-13  
Bavencio : EPAR - Summary for the public NL = Nederlands 2017-10-13  
Bavencio : EPAR - Summary for the public PL = polski 2017-10-13  
Bavencio : EPAR - Summary for the public PT = português 2017-10-13  
Bavencio : EPAR - Summary for the public RO = română 2017-10-13  
Bavencio : EPAR - Summary for the public SK = slovenčina 2017-10-13  
Bavencio : EPAR - Summary for the public SL = slovenščina 2017-10-13  
Bavencio : EPAR - Summary for the public FI = suomi 2017-10-13  
Bavencio : EPAR - Summary for the public SV = svenska 2017-10-13  
Bavencio : EPAR - Summary for the public HR = Hrvatski 2017-10-13  

This EPAR was last updated on 13/10/2017 .

Authorisation details

Product details

Product details for Bavencio
NameBavencio
Agency product numberEMEA/H/C/004338
Active substance

avelumab

International non-proprietary name (INN) or common name

avelumab

Therapeutic area Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code L01XC
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 Bavencio
Marketing-authorisation holder

Merck Serono Europe Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/09/2017

Contact address:

Merck Serono Europe Limited
56 Marsh Wall
London E14 9TP
United Kingdom

Product information

Product information

18/09/2017  Bavencio -EMEA/H/C/004338

Name Language First published Last updated
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  
Bavencio : EPAR - Product Information HR = Hrvatski 2017-10-13  

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
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  
Bavencio : EPAR - All Authorised presentations HR = Hrvatski 2017-10-13  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Bavencio : EPAR - Public assessment report HR = Hrvatski 2017-10-13  
CHMP summary of positive opinion for Bavencio HR = Hrvatski 2017-07-21  

Authorised

This medicine is approved for use in the European Union

Related information