Yervoy

ipilimumab

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An overview of Yervoy and why it is authorised in the EU

What is Yervoy and what is it used for?

Yervoy is a medicine that increases the activity of the immune system (the body’s natural defences) and is used to treat patients with advanced melanoma (a type of skin cancer affecting cells called melanocytes). It can be used either alone in adults and children aged from 12 years or with nivolumab (another cancer medicine) in adults.

Yervoy contains the active substance ipilimumab.

How is Yervoy used?

Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.

The recommended dose of Yervoy is 3 mg per kilogram body weight given by infusion (drip) into a vein over 90 minutes. When Yervoy is used alone, the patient receives a dose every 3 weeks for a total of 4 doses. When used with nivolumab, the patient receives a dose of Yervoy and of nivolumab every 3 weeks for 4 doses followed by treatment with nivolumab alone.

The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.

For more information about using Yervoy, see the package leaflet or contact a doctor or pharmacist.

How does Yervoy work?

The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target in the body.

Ipilimumab acts on a type of white blood cells called T cells which form part of the immune system. It attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells. By blocking CTLA-4, ipilimumab activates and increases T cells, which enter into tumours and kill the tumour cells.

What benefits of Yervoy have been shown in studies?

Two main studies found Yervoy effective in improving how long patients with advanced melanoma lived.

The first study involved 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working. Overall survival with Yervoy (3 mg per kg) and with Yervoy combined with an experimental medicine called ‘gp100’ was 10 months, compared with 6 months in patients receiving gp100 alone.

The second study involved 502 adults whose advanced melanoma had not been treated previously. Patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine. However, about one- third of the patients could not complete Yervoy treatment due to side effects.

In a further study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg. However, patients treated with the higher dose had more side effects and were less likely to complete treatment as a result. Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.

In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults. The effects of Yervoy in adolescents are expected to be similar to those in adults. Because the medicine has been studied in very few adolescents, there is uncertainty about the medicine’s side effects. Therefore, all adolescents treated with Yervoy will be monitored closely.

Another main study found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1. In the first study involving 945 adults, patients treated with Yervoy and nivolumab lived for

11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone. In an additional study involving 142 patients, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.

What are the risks associated with Yervoy?

Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation. Most will improve with appropriate treatment or on stopping Yervoy. The most common side effects (which may affect more than 1 in 10 people) are diarrhoea, rash, itching, tiredness, nausea (feeling sick), vomiting, decreased appetite and abdominal pain (belly ache). Additional common side effects when Yervoy is used with nivolumab include fever, reduced levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.

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

Why is Yervoy authorised in the EU?

The European Medicines Agency noted that Yervoy improves survival in a condition where overall survival rates are low. The most frequent side effects of the medicine are mild to moderate in severity. Because studies with Yervoy have included very few adolescents, the company has committed to collecting information on side effects, including any effects on growth and sexual maturation.

The Agency decided that Yervoy’s benefits are greater than its risks and recommended that it be given marketing authorisation. Despite longer survival with a dose of 10 mg per kg, the Agency recommended using Yervoy at a dose of 3 mg per kg because the higher dose caused more side effects and worsened patients’ quality of life after the start of treatment.

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

The company that markets Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are given a brochure with safety information on the medicine including the side effects resulting from excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.

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

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

Other information about Yervoy

Yervoy received a marketing authorisation valid throughout the EU on 13 July 2011.

Name Language First published Last updated
Yervoy : EPAR - Medicine overview BG = bălgarski 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview ES = español 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview CS = čeština 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview DA = dansk 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview DE = Deutsch 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview ET = eesti keel 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview EL = elliniká 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview EN = English 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview FR = français 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview IT = italiano 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview LV = latviešu valoda 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview LT = lietuvių kalba 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview HU = magyar 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview MT = Malti 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview NL = Nederlands 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview PL = polski 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview PT = português 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview RO = română 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview SK = slovenčina 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview SL = slovenščina 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview FI = suomi 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview SV = svenska 2011-07-25 2018-07-30
Yervoy : EPAR - Medicine overview HR = Hrvatski 2011-07-25 2018-07-30

This EPAR was last updated on 30/07/2018 .

Authorisation details

Product details

Product details for Yervoy
NameYervoy
Agency product numberEMEA/H/C/002213
Active substance

ipilimumab

International non-proprietary name (INN) or common name

ipilimumab

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01XC11

Publication details

Publication details for Yervoy
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision23
Date of issue of marketing authorisation valid throughout the European Union13/07/2011

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
United Kingdom

Product information

Product information

14/06/2018  Yervoy -EMEA/H/C/002213 -II/0054

Name Language First published Last updated
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30
Yervoy : EPAR - Product Information HR = Hrvatski 2011-07-25 2018-07-30

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
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  
Yervoy : EPAR - All Authorised presentations HR = Hrvatski 2011-07-25  

Name Language First published Last updated
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  
Yervoy : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 2011-07-25  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Yervoy as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.

Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Yervoy : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2012-07-02 2018-07-30
Yervoy-H-C-2213-II-0055 : EPAR - Assessment Report - Variation HR = Hrvatski 2018-06-05  
CHMP post-authorisation summary of positive opinion for Yervoy (II-55) HR = Hrvatski 2018-04-27  
Yervoy-H-C-002213-II-0044 : EPAR - Assessment Report - Variation HR = Hrvatski 2018-01-29  
Yervoy : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 2018-01-29  
Yervoy-H-C-PSUSA-00009200-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 2018-01-12  
CHMP post-authorisation summary of positive opinion for Yervoy (II-44) HR = Hrvatski 2017-12-15  
Yervoy-H-C-2213-P46-034.1 : EPAR - Assessment Report HR = Hrvatski 2017-09-28  
Yervoy-H-C-PSUSA-00009200-201503: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2016-02-01  
Yervoy-H-C-PSUSA-00009200-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2015-08-26  
Yervoy-H-C-2213-P46-0032 : EPAR - Assessment Report HR = Hrvatski 2015-03-24  
Yervoy-H-C-2213-PSUV-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2014-03-11  
Yervoy-H-C-2213-II-0008 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-12-05  
CHMP post-authorisation summary of positive opinion for Yervoy HR = Hrvatski 2013-09-20  

Initial marketing-authorisation documents

Name Language First published Last updated
Yervoy : EPAR - Public assessment report HR = Hrvatski 2011-07-25  
CHMP summary of positive opinion for Yervoy HR = Hrvatski 2011-05-20