Keytruda

pembrolizumab

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

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

What is Keytruda and what is it used for?

Keytruda is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.

Keytruda contains the active substance pembrolizumab.

How is Keytruda used?

Treatment with Keytruda must be started and supervised by a doctor experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.

Keytruda is available as a powder that is made up into a solution for infusion (drip) into a vein. The infusion is given at a recommended dose of 2 mg per kilogram body weight over 30 minutes every three weeks. The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe. Treatment is continued until the disease gets worse or side effects become unmanageable.

For further information, see the summary of product characteristics.

How does Keytruda work?

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Pembrolizumab has been designed to attach to and block a receptor called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells, thereby increasing the ability of the immune system to kill melanoma cells.

What benefits of Keytruda have been shown in studies?

Keytruda has been shown to be effective in treating patients with melanoma that could not be treated by surgery or had spread throughout the body in two main studies.

The first study included 540 patients who were previously treated with another monoclonal antibody medicine for melanoma, ipilimumab. Patients received either Keytruda 2 mg/kg every three weeks or Keytruda 10 mg/kg every three weeks or chemotherapy (medicines used to treat cancer). Early results showed that 6 months after start of treatment, the disease had not worsened in 34% of patients treated with Keytruda compared with 16% of patients treated with chemotherapy.

The second study looked at 834 patients who were not previously treated with ipilimumab. Patients received either Keytruda or ipilimumab. Early results showed that the patients treated with Keytruda lived for up to 5.5 months without their disease getting worse compared with 2.8 months with ipilimumab. The study also found that the overall survival of patients treated with Keytruda was longer than for patients who received ipilimumab. Up 71% of patients lived for at least 12 months after start of their treatment compared with 58% of patients on ipilimumab.

What are the risks associated with Keytruda?

The most common side effects with Keytruda (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), pruritus (itching), rash, arthralgia (joint pain) and fatigue (tiredness), most of which are mild to moderate in severity. Other common side effects of Keytruda related to the activity of the immune system causing inflammation of body organs. Most will resolve following appropriate treatment or on stopping Keytruda.

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

Why is Keytruda approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma. The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable with the existing recommendations.

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

A risk management plan has been developed to ensure that Keytruda is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Keytruda, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Keytruda will provide educational packs for doctors who are expected to prescribe Keytruda containing information on how the medicine should be used and how to manage side effects, particularly side effects related to the activity of the immune system. The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.

The company will also provide the final results of the studies with Keytruda to confirm the long-term benefits of the medicine. In addition, the company will further evaluate the 2mg/kg and 10 mg/kg dose in specific patients and will also carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.

Further information can be found in the summary of the risk management plan.

Other information about Keytruda

The European Commission granted a marketing authorisation valid throughout the European Union for Keytruda on 17 July 2015.

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

Name Language First published Last updated
Keytruda : EPAR - Summary for the public BG = bălgarski 30/07/2015  
Keytruda : EPAR - Summary for the public ES = español 30/07/2015  
Keytruda : EPAR - Summary for the public CS = čeština 30/07/2015  
Keytruda : EPAR - Summary for the public DA = dansk 30/07/2015  
Keytruda : EPAR - Summary for the public DE = Deutsch 30/07/2015  
Keytruda : EPAR - Summary for the public ET = eesti keel 30/07/2015  
Keytruda : EPAR - Summary for the public EL = elliniká 30/07/2015  
Keytruda : EPAR - Summary for the public EN = English 30/07/2015  
Keytruda : EPAR - Summary for the public FR = français 30/07/2015  
Keytruda : EPAR - Summary for the public IT = italiano 30/07/2015  
Keytruda : EPAR - Summary for the public LV = latviešu valoda 30/07/2015  
Keytruda : EPAR - Summary for the public LT = lietuvių kalba 30/07/2015  
Keytruda : EPAR - Summary for the public HU = magyar 30/07/2015  
Keytruda : EPAR - Summary for the public MT = Malti 30/07/2015  
Keytruda : EPAR - Summary for the public NL = Nederlands 30/07/2015  
Keytruda : EPAR - Summary for the public PL = polski 30/07/2015  
Keytruda : EPAR - Summary for the public PT = português 30/07/2015  
Keytruda : EPAR - Summary for the public RO = română 30/07/2015  
Keytruda : EPAR - Summary for the public SK = slovenčina 30/07/2015  
Keytruda : EPAR - Summary for the public SL = slovenščina 30/07/2015  
Keytruda : EPAR - Summary for the public FI = suomi 30/07/2015  
Keytruda : EPAR - Summary for the public SV = svenska 30/07/2015  
Keytruda : EPAR - Summary for the public HR = Hrvatski 30/07/2015  
Name Language First published Last updated
Keytruda : EPAR - Risk-management-plan summary (English only) 30/07/2015  

This EPAR was last updated on 03/05/2016 .

Authorisation details

Product details

Product details for Keytruda
NameKeytruda
Agency product numberEMEA/H/C/003820
Active substance

pembrolizumab

International non-proprietary name (INN) or common name

pembrolizumab

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01
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.

Publication details

Publication details for Keytruda
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision2
Date of issue of marketing authorisation valid throughout the European Union17/07/2015

Contact address:

Merck Sharp & Dohme Limited
Hertford road 
Hoddesdon
EN11 9BU
United Kingdom

Product information

Product information

01/04/2016  Keytruda -EMEA/H/C/003820 -II/0002

Name Language First published Last updated
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016
Keytruda : EPAR - Product Information EN = English 30/07/2015 03/05/2016

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
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  
Keytruda : EPAR - All Authorised presentations EN = English 30/07/2015  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Keytruda : EPAR - Procedural steps taken and scientific information after authorisation EN = English 29/03/2016 03/05/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Keytruda : EPAR - Public assessment report EN = English 30/07/2015  
CHMP summary of positive opinion for Keytruda EN = English 22/05/2015