Lenvatinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 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).
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