Lenvatinib

Lenvatinib (Kisplyx, Lenvima, Eisai GmbH) has 5 EU-approved indications in 4 tumour types.
Approved indications of Lenvatinib
Biomarker requirementRegimenSettingConditions
Hepatocellular carcinoma1
None
Monotherapy
1L
advanced
None
Endometrial cancer1
None
+ pembrolizumab
Any line
advanced
Disease progression on or following prior treatment with a platinum-containing therapy in any setting; Not candidates for curative surgery or radiation
Renal cell carcinoma2
None
+ pembrolizumab
1L
advanced
None
None
+ everolimus
2L
advanced
After one prior vascular endothelial growth factor (VEGF)-targeted therapy
Thyroid cancer1
None
Monotherapy
Any line
advanced
Differentiated thyroid cancer only; Refractory to radioactive iodine (RAI); progressive disease
Full text of section 4.1 (therapeutic indications)
Kisplyx

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 (see section 5.1).

Lenvima

Differentiated Thyroid Carcinoma (DTC) LENVIMA as monotherapy is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Hepatocellular Carcinoma (HCC) LENVIMA as monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1). Endometrial Carcinoma (EC) LENVIMA in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Label history

30 changes to the Kisplyx label since 2017, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Product

Changes