Table of contents
Kisplyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer). It is used with another cancer medicine, pembrolizumab, when patients have not had previous treatment for their cancer. Kisplyx is also used with the cancer medicine everolimus in patients who have been previously treated with a type of cancer medicine called a vascular endothelial growth factor (VEGF) inhibitor.
Kisplyx contains the active substance lenvatinib.
Kisplyx : EPAR - Summary for the public (PDF/122.03 KB)
First published: 16/11/2016
Last updated: 30/11/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Renal Cell
|Anatomical therapeutic chemical (ATC) code||
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
|Date of issue of marketing authorisation valid throughout the European Union||
14/04/2023 Kisplyx - EMEA/H/C/004224 - II/0052
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):
- in combination with pembrolizumab, as first-line treatment (see section 5.1).
- in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.