Keytruda

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pembrolizumab

Authorised
This medicine is authorised for use in the European Union.

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),

• oesophageal cancer (cancer of the gullet or food pipe), including a type of cancer at the junction between the oesophagus and the stomach,

• a kind of breast cancer called triple-negative breast cancer,

• endometrial carcinoma (a cancer of the lining of the womb),

• cervical cancer (a cancer of the cervix),

• the following cancers described as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) located in:

  • colorectal cancer (a cancer of the colon or rectum, the lower part of the gut),
  • endometrial carcinoma (a cancer of the lining of the womb),
  • gastric cancer (a cancer of the stomach), small intestine cancer, biliary cancer (a cancer of the bile ducts or gallbladder).

Keytruda is mainly used in adults for cancers that are advanced, have spread or returned, are not responding to other treatments or cannot be removed by surgery. Keytruda is also used in children aged 3 years and older with classical Hodgkin lymphoma, and in adolescents aged 12 years and older with melanoma. In some cancers, it is only given to patients whose tumours produce certain levels of a protein known as PD-L1 or are determined to be as MSI-H or dMMR.

Keytruda is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma or renal cell carcinoma (adjuvant therapy).

For oesophageal cancer, cervical cancer and triple-negative breast cancer, Keytruda is used in combination with chemotherapy or other cancer medicines. In some patients with triple-negative breast cancer Keytruda can be given before (neoadjuvant treatment) and after (adjuvant treatment) surgery. It can be used on its own or in combination with other cancer medicines for NSCLC, HNSCC, endometrial carcinoma and renal cell carcinoma. For the other cancers, Keytruda is only used on its own.

Keytruda contains the active substance pembrolizumab.

This EPAR was last updated on 26/07/2022

Authorisation details

Product details
Name
Keytruda
Agency product number
EMEA/H/C/003820
Active substance
Pembrolizumab
International non-proprietary name (INN) or common name
pembrolizumab
Therapeutic area (MeSH)
  • Melanoma
  • Hodgkin Disease
  • Carcinoma, Renal Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Transitional Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Urologic Neoplasms
  • Endometrial Neoplasms
Anatomical therapeutic chemical (ATC) code
  • L01XC18
  • L01FF02
Additional monitoringAdditional 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
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
47
Date of issue of marketing authorisation valid throughout the European Union
17/07/2015
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

16/06/2022 Keytruda - EMEA/H/C/003820 - II/0122

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Melanoma
KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or 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).

KEYTRUDA, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults (see section 5.1).

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1).

Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers
Colorectal cancer (CRC)
KEYTRUDA as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings:

- first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults;

 - treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. 

Non-colorectal cancers
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with:

- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;

- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

Oesophageal carcinoma
KEYTRUDA, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD L1 with a CPS ≥ 10 (see section 5.1).

Triple negative breast cancer (TNBC)
KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence (see section 5.1).

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).

Endometrial carcinoma (EC)
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.

Cervical cancer
KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1.

Assessment history

Changes since initial authorisation of medicine

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