Keytruda

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Questions & Answers

On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme Limited.

The CHMP adopted a new indication as follows:

"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."

For information, the full indications for Keytruda will be as follows1:

"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.

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."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Keytruda (English only) 2017-07-21  

Key facts

Product details for Keytruda
NameKeytruda
INN or common name

pembrolizumab

Therapeutic area Carcinoma, Non-Small-Cell LungHodgkin DiseaseMelanoma
Active substance

pembrolizumab

Date opinion adopted20/07/2017
Company name

Merck Sharp & Dohme Ltd

StatusPositive
Application typePost authorisation