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 medicine used to treat the following cancers:

  • melanoma (a skin cancer) that has spread or cannot be removed with surgery;
  • a type of lung cancer known as non-small cell lung cancer (NSCLC). Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body;
  • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell). Keytruda is used only after failure of treatments with brentuximab vedotin and an autologous stem cell transplant (ASCT, a type of transplant used to replace the bone marrow with the patient’s own stem cells), or after brentuximab vedotin has failed and a transplant is not possible;
  • urothelial cancer (a cancer of the bladder and urinary tract) that is advanced or has spread to other parts of the body. Keytruda is used in patients who have previously been treated with platinum-based cancer medicines or who cannot be treated with cisplatin-containing cancer medicines.

The medicine contains the active substance pembrolizumab.

How is Keytruda used?

Keytruda is given as an infusion (drip) into a vein once every three weeks. The recommended dose for previously untreated NSCLC, classical Hodgkin lymphoma and urothelial cancer is 200 mg. For melanoma and previously treated NSCLC, the dose depends on the patient’s weight and is 2 mg per kilogram body weight.

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.

Hodgkin lymphoma

Keytruda has been shown to be effective at partially or completely clearing the cancer cells in classical Hodgkin lymphoma that had not responded to or returned after treatment with brentuximab vedotin, with or without an autologous stem cell transplant.

In a main study of 210 patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 145 patients (69%); a complete remission occurred in 47 (22%) of them, meaning they no longer had any signs of cancer. The average time that the response lasted and patients lived without their disease getting worse again was around 11 months.

Urothelial cancer

Keytruda has been also shown to be effective in improving survival of patients with urothelial cancer.

A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine). Patients lived longer with Keytruda (around 10 months) than with the other cancer medicines (around 7 months), although Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).

In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 27 (7%) of them, meaning they no longer had any signs of cancer.

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

The Agency considered that study results 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 Urothelial cancer, Keytruda has been also shown to be effective in improving survival of patients with urothelial cancer.

A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine). Patients lived longer with Keytruda (around 10 months) than with the other cancer medicines (around 7 months), although Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).

In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 27 (7%) of them, meaning they no longer had any signs of cancer. Agency 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.

In classical Hodgkin lymphoma, the Agency considered the responses seen so far to be clinically significant in this group of patients, in whom other treatments had failed and who had few other treatment options. The safety of the medicine in this condition otherwise appeared comparable to that in its other uses.

In urothelial cancer, Keytruda helps prolong survival. In previously treated patients, the effects of Keytruda may be delayed and this should be considered when treating patients who have a poor prognosis or aggressive disease. The safety of the medicine in urothelial cancer appeared similar to that in its other uses and compares well to 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. Information on the risks of being given donor stem cell transplants after Keytruda treatment will also be included. The company will 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 2017-10-12
Keytruda : EPAR - Summary for the public ES = español 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public CS = čeština 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public DA = dansk 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public DE = Deutsch 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public ET = eesti keel 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public EL = elliniká 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public FR = français 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public IT = italiano 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public LV = latviešu valoda 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public LT = lietuvių kalba 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public HU = magyar 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public MT = Malti 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public NL = Nederlands 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public PL = polski 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public PT = português 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public RO = română 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public SK = slovenčina 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public SL = slovenščina 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public FI = suomi 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public SV = svenska 2015-07-30 2017-10-12
Keytruda : EPAR - Summary for the public HR = Hrvatski 2015-07-30 2017-10-12
Name Language First published Last updated
Keytruda : EPAR - Risk-management-plan summary (English only) 2015-07-30  

This EPAR was last updated on 12/10/2017 .

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 Carcinoma, Non-Small-Cell LungHodgkin DiseaseMelanoma
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

Revision10
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

24/08/2017  Keytruda -EMEA/H/C/003820 -II/0023/G

Name Language First published Last updated
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12
Keytruda : EPAR - Product Information EN = English 2015-07-30 2017-10-12

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.

Keytruda as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

Assessment History