/Human medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 23, Status: Authorised

NEWS

Human medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 23, Status: Authorised

EMA

2026/05/21

Human medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 23, Status: Authorised

Application under evaluation
CHMP opinion
European Commission decision

Overview

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;
Renal cell carcinoma (RCC, a cancer of the kidney), when the cancer is advanced; Bavencio is used in combination with another cancer medicine, axitinib;
Urothelial carcinoma (a type of bladder cancer), when the cancer is locally advanced or has spread to other parts of the body in patients whose cancer had not got worse after platinum-based chemotherapy.

Bavencio contains the active substance avelumab.

Expand section

Collapse section

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 in a dose of 800 mg once every two weeks as an infusion (drip) into a vein that lasts around one hour. 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. Treatment may need to be delayed or stopped if certain side effects occur.

For more information about using Bavencio, see the package leaflet or contact your doctor or pharmacist.

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 has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse. Although the dose of Bavencio in these studies was based on the patients’ body weight, the company also supplied supporting data to show that Bavencio could be given in a standard dose, regardless of weight.

Merkel cell carcinoma

In a main study, around 33% of patients with MCC who had received previous treatment (29 out of 88) had a reduction in tumour size or no sign of it after treatment with Bavencio; in most of these patients, the response lasted for at least 6 months.

Results from the same study for 116 patients with metastatic MCC who had not received chemotherapy in the previous 6 months showed an overall response rate of 40%.

Renal cell carcinoma

In a main study involving 886 patients with advanced RCC, who had not been previously treated, Bavencio infusion in combination with axitinib by mouth was compared with standard treatment using another cancer medicine, sunitinib. The average time patients lived without their disease getting worse was around 13 months in those given Bavencio and axitinib versus 8 months in those given sunitinib. Longer follow-up is needed to draw a reliable conclusion on how well patients given Bavencio and axitinib survive overall.

Urothelial cancer

Bavencio given together with best supportive care (any treatment to prevent or relieve the symptoms of the disease, but not other anticancer medicines) was compared with best supportive care only in a main study including 700 patients with urothelial cancer that was advanced or had spread to other parts of the body and did not get worst after treatment with chemotherapy. Patients who received Bavencio lived on average for 22 months compared with around 15 months of patients receiving best supportive care.

What are the risks associated with Bavencio?

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

When Bavencio is used with axitinib the most common side effects (which may affect more than 1 in 5 people) are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).

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

Why is Bavencio authorised in the EU?

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

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, data from the study show that some patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response.

In patients with urothelial cancer that was advanced or had spread to other parts of the body and did not get worst after treatment with platinum-based chemotherapy, Bavencio was shown to prolong patients' lives in comparison to best supportive care.

The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.

In patients with advanced RCC, Bavencio plus axitinib has been shown to improve the length of time patients survive without their disease getting worse when compared with sunitinib, though how long patients survive overall remains to be shown. The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.

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

The company that markets Bavencio will issue educational materials for 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.

As for all medicines, data on the use of Bavencio are continuously monitored. Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.

Other information about Bavencio

Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017. This was switched to a full marketing authorisation on 19 August 2020.

Bavencio : EPAR - Medicine overview

Reference Number:

EMA/584705/2022

English (EN) (158.66 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Other languages (22)

български (BG) (175.23 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

español (ES) (148.3 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

čeština (CS) (172.6 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

dansk (DA) (146.62 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Deutsch (DE) (151.41 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

eesti keel (ET) (135.15 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

ελληνικά (EL) (174.32 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

français (FR) (150.12 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

hrvatski (HR) (172.47 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

italiano (IT) (148.27 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

latviešu valoda (LV) (179.79 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

lietuvių kalba (LT) (171.55 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

magyar (HU) (173.37 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Malti (MT) (175.4 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Nederlands (NL) (147.3 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

polski (PL) (175.89 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

português (PT) (149.14 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

română (RO) (172.25 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

slovenčina (SK) (172.45 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

slovenščina (SL) (170.46 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Suomi (FI) (144.87 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

svenska (SV) (145.35 KB - PDF)

First published:

13/10/2017

Last updated:

26/07/2022

View

Bavencio : EPAR - Risk management plan

English (EN) (2.2 MB - PDF)

First published:

04/11/2019

Last updated:

21/05/2026

View

Product information

Bavencio : EPAR - Product Information

English (EN) (567.23 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Other languages (24)

български (BG) (747.15 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

español (ES) (667.66 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

čeština (CS) (820.17 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

dansk (DA) (579.25 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Deutsch (DE) (667.31 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

eesti keel (ET) (603.53 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

ελληνικά (EL) (746.28 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

français (FR) (707.25 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

hrvatski (HR) (787.07 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

íslenska (IS) (601.21 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

italiano (IT) (641.27 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

latviešu valoda (LV) (701.67 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

lietuvių kalba (LT) (702.08 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

magyar (HU) (805.68 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Malti (MT) (718.07 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Nederlands (NL) (598.66 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

norsk (NO) (592.32 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

polski (PL) (708.13 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

português (PT) (609.59 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

română (RO) (715.82 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

slovenčina (SK) (723.51 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

slovenščina (SL) (706.16 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Suomi (FI) (615.98 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

svenska (SV) (653.08 KB - PDF)

First published:

13/10/2017

Last updated:

21/05/2026

View

Latest procedure affecting product information:

VR/0000314741

10/04/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

Bavencio : EPAR - All Authorised presentations

English (EN) (11.79 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Other languages (24)

български (BG) (33.15 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

español (ES) (11.2 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

čeština (CS) (30.2 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

dansk (DA) (11 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Deutsch (DE) (11.08 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

eesti keel (ET) (11.03 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

ελληνικά (EL) (34.58 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

français (FR) (11.06 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

hrvatski (HR) (28.55 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

íslenska (IS) (10.99 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

italiano (IT) (11.12 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

latviešu valoda (LV) (60.9 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

lietuvių kalba (LT) (28.2 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

magyar (HU) (18.97 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Malti (MT) (32.38 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Nederlands (NL) (11.12 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

norsk (NO) (11.1 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

polski (PL) (32.12 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

português (PT) (11.16 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

română (RO) (30.33 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

slovenčina (SK) (74 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

slovenščina (SL) (18.67 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Suomi (FI) (11.24 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

svenska (SV) (11.08 KB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

Product details

Name of medicine

Bavencio

International non-proprietary name (INN) or common name

avelumab

Therapeutic area (MeSH)

Neuroendocrine Tumors

Anatomical therapeutic chemical (ATC) code

L01FF04

Pharmacotherapeutic group

Other antineoplastic agents
Monoclonal antibodies

Therapeutic indication

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

Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.

Authorisation details

EMA product number

EMEA/H/C/004338

Marketing authorisation holder

Merck Europe B.V.

Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands

Opinion adopted

20/07/2017

Marketing authorisation issued

18/09/2017

Revision

Assessment history

Expand section

Collapse section

Changes since initial authorisation of medicine

Bavencio : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (172.67 KB - PDF)

First published:

22/01/2026

Last updated:

21/05/2026

View

Bavencio : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (248.62 KB - PDF)

First published:

17/01/2018

Last updated:

22/01/2026

View

Bavencio-H-C-PSUSA-00010635-202303 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted

Reference Number:

EMA/12383/2024

English (EN) (103.94 KB - PDF)

First published:

10/01/2024

View

Bavencio-H-C-004338-P46-009 : EPAR - Assessment report

Adopted

Reference Number:

EMA/155892/2022

English (EN) (671.56 KB - PDF)

First published:

05/04/2022

View

Bavencio-H-C-PSUSA-00010635-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/760025/2021

English (EN) (124.2 KB - PDF)

First published:

21/01/2022

View

Bavencio-H-C-004338-II-0018 : EPAR - Assessment report - Variation

Adopted

Reference Number:

EMA/CHMP/3166/2021

English (EN) (7.4 MB - PDF)

First published:

11/02/2021

View

CHMP post-authorisation summary of positive opinion for Bavencio (II-18)

Adopted

Reference Number:

EMA/CHMP/627792/2020

English (EN) (128.1 KB - PDF)

First published:

11/12/2020

View

Bavencio-H-C-004338-II-0013 : EPAR - Assessment report - Variation

Adopted

Reference Number:

EMA/CHMP/333708/2020

English (EN) (938.01 KB - PDF)

First published:

31/08/2020

View

Bavencio-H-C-004338-II-0009-G : EPAR - Assessment report - Variation

English (EN) (5.64 MB - PDF)

First published:

04/11/2019

View

CHMP post-authorisation summary of positive opinion for Bavencio (II-09)

Adopted

Reference Number:

EMA/CHMP/473440/2019

English (EN) (114.8 KB - PDF)

First published:

20/09/2019

View

Bavencio-H-C-PSUSA-00010635-201809 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted

Reference Number:

EMA/CHMP/357412/2019

English (EN) (112.11 KB - PDF)

First published:

25/06/2019

View

Initial marketing authorisation documents

Bavencio : EPAR - Public assessment report

Adopted

Reference Number:

EMA/496529/2017

English (EN) (4.54 MB - PDF)

First published:

13/10/2017

Last updated:

13/10/2017

View

CHMP summary of positive opinion for Bavencio

Reference Number:

EMA/CHMP/426201/2017

English (EN) (61.97 KB - PDF)

First published:

21/07/2017

Last updated:

21/07/2017

View

News on Bavencio

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020

11/12/2020

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019

20/09/2019

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

21/07/2017

Summary

Human medicines European public assessment report (EPAR): Bavencio, avelumab, Date of authorisation: 18/09/2017, Revision: 23, Status: Authorised