This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 25/05/2023

Authorisation details

Product details
Agency product number
Active substance
lenvatinib mesilate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

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.

Publication details
Marketing-authorisation holder
Eisai GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Edmund-Rumpler-Straße 3
60549 Frankfurt am Main

Product information

14/04/2023 Kisplyx - EMEA/H/C/004224 - II/0052

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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

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.

Assessment history

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