Keytruda
pembrolizumab
Table of contents
Overview
Keytruda is a cancer medicine used to treat:
- melanoma, a skin cancer,
- non-small cell lung cancer (NSCLC), a type of lung cancer,
- classical Hodgkin lymphoma, a cancer of the white blood cells,
- urothelial cancer, a cancer of the bladder and urinary tract,
- a cancer affecting the head and neck known as head and neck squamous cell carcinoma (HNSCC),
- renal cell carcinoma (a type of kidney cancer).
Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments. In some cancers, it is only given to patients whose tumours produce high levels of a protein known as PD-L1.
Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).
For renal cell carcinoma, Keytruda is used in combination with other cancer medicines. It can be used on its own or in combination with other cancer medicines for NSCLC and HNSCC. For the other cancers, Keytruda is only used on its own.
Keytruda contains the active substance pembrolizumab.
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List item
Keytruda : EPAR - Medicine overview (PDF/163.73 KB)
First published: 30/07/2015
Last updated: 11/12/2019
EMA/559197/2018 -
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List item
Keytruda : EPAR - Risk-management-plan summary (PDF/1.7 MB)
First published: 30/07/2015
Last updated: 15/03/2021
Authorisation details
Product details | |
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Name |
Keytruda
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Agency product number |
EMEA/H/C/003820
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Active substance |
Pembrolizumab
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International non-proprietary name (INN) or common name |
pembrolizumab
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L01XC18
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
32
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Date of issue of marketing authorisation valid throughout the European Union |
17/07/2015
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Contact address |
Waarderweg 39 |
Product information
09/03/2021 Keytruda - EMEA/H/C/003820 - II/0090
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.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Melanoma
Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Keytruda as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
Non small cell lung carcinoma (NSCLC)
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.
Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults.
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma 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.
Classical Hodgkin lymphoma (cHL)
Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
Urothelial carcinoma
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Head and neck squamous cell carcinoma (HNSCC)
Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ≥ 50% TPS and progressing on or after platinum containing chemotherapy (see section 5.1).
Renal cell carcinoma (RCC)
Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults (see section 5.1).
Colorectal cancer (CRC)
Keytruda as monotherapy is indicated for the first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
Melanoma
Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Keytruda as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
Non small cell lung carcinoma (NSCLC)
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.
Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults.
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma 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.
Classical Hodgkin lymphoma (cHL)
Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) following at least two prior therapies when ASCT is not a treatment option.
Urothelial carcinoma
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Head and neck squamous cell carcinoma (HNSCC)
Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1).
Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ≥ 50% TPS and progressing on or after platinum containing chemotherapy (see section 5.1).
Renal cell carcinoma (RCC)
Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults (see section 5.1).
Colorectal cancer (CRC)
Keytruda as monotherapy is indicated for the first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 202129/01/2021
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
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30/04/2020
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 202031/01/2020
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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26/07/2019
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 201819/10/2018
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27/07/2018
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01/06/2018
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01/06/2018
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10/11/2017
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21/07/2017
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24/03/2017
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16/12/2016
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24/06/2016
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22/05/2015
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22/05/2015