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).

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.

This EPAR was last updated on 11/12/2019

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, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01
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
24
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

14/11/2019 Keytruda - EMEA/H/C/003820 - II/0065

Contents

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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 adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

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, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC 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 NSCLC in adults.

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.

Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

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.

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 (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

Keytruda, as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy.

Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.

Assessment history

Changes since initial authorisation of medicine

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