Keytruda

RSS

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)

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 used on its own except for non-squamous NSCLC when it is used in combination with pemetrexed and platinum chemotherapy.

Keytruda contains the active substance pembrolizumab.

This EPAR was last updated on 10/10/2018

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 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
15
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

04/09/2018 Keytruda - EMEA/H/C/003820 - II/0042

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

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, 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 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 is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy.

Assessment history

Changes since initial authorisation of medicine

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