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 for treating melanoma (a skin cancer) and a type of lung cancer known as non-small cell lung cancer (NSCLC), when these cancers have spread or cannot be surgically removed.

In lung cancer, Keytruda is specifically for lung tumours that produce a protein known as PD-L1.

The medicine contains the active substance pembrolizumab.

How is Keytruda used?

Keytruda is given as an infusion into a vein once every three weeks. The recommended dose is 2 mg per kilogram body weight for melanoma and previously treated NSCLC and 200 mg for previously untreated NSCLC.

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 patients with lung cancer, doctors should test the tumours to check if the cancer cells produce the PD-L1 protein before starting treatment.

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

For further information, see the summary of product characteristics (also part of the EPAR).

How does Keytruda work?

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and block a receptor called PD-1. Some cancers can make a protein that combines with PD-1 to switch off the activity of certain cells of the immune system (the body’s natural defences) preventing them from attacking the cancer. By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

What benefits of Keytruda have been shown in studies?

Skin cancer

Keytruda has been shown to be effective in delaying worsening of melanoma and improving survival. Early results from a study of 540 previously treated melanoma patients 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.

A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab. Early results from this study 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 patients treated with Keytruda lived longer than patients who received ipilimumab. Up to 71% of patients lived for at least 12 months after start of their treatment compared with 58% of patients on ipilimumab.

Lung cancer

Keytruda has been also shown to be effective in delaying worsening of the disease and improving survival in patients with NSCLC that tested positive for the PD-L1 protein.

In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments. Keytruda was more effective in those patients who tested strongly for PD-L1, with these patients living for 15 months on average and for 5 months without their disease worsening.

In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients taking platinum-based chemotherapy.

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), itching, rash, joint pain and 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 respect to NSCLC, the CHMP noted that Keytruda helps prolong survival and slows the worsening of the disease. The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of chemotherapy.

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

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 on 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.

In addition, the company will provide the final results of the studies with Keytruda to confirm the long-term benefits of the medicine. Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.

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

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 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public ES = español 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public CS = čeština 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public DA = dansk 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public DE = Deutsch 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public ET = eesti keel 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public EL = elliniká 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public EN = English 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public FR = français 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public IT = italiano 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public LV = latviešu valoda 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public LT = lietuvių kalba 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public HU = magyar 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public MT = Malti 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public NL = Nederlands 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public PL = polski 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public PT = português 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public RO = română 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public SK = slovenčina 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public SL = slovenščina 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public FI = suomi 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public SV = svenska 2015-07-30 2017-03-02
Keytruda : EPAR - Summary for the public HR = Hrvatski 2015-07-30 2017-03-02
Name Language First published Last updated
Keytruda : EPAR - Risk-management-plan summary (English only) 2015-07-30  

This EPAR was last updated on 02/03/2017 .

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

Revision6
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

27/01/2017  Keytruda -EMEA/H/C/003820 -II/0011

Name Language First published Last updated
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-02-03

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 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28
Keytruda : EPAR - All Authorised presentations EN = English 2015-07-30 2016-09-28

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

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