# Lenvatinib

Lenvatinib (Kisplyx, Lenvima, Eisai GmbH) has 5 EU-approved indications in 4 tumour types.

## Approved indications

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line, advanced | - |

### Endometrial cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + pembrolizumab | 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 carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + pembrolizumab | 1st line, advanced | - |
| None | + everolimus | 2nd line, advanced | After one prior vascular endothelial growth factor (VEGF)-targeted therapy |

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Differentiated thyroid cancer only; Refractory to radioactive iodine (RAI); progressive disease |

## Products

### Kisplyx

- Company: Eisai GmbH
- Target: Multikinase inhibitor (VEGFR, FGFR, PDGFRα, KIT, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX08
- EU approval: 25 Aug 2016
- Label revised: 26 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kisplyx-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kisplyx

Mechanism (SmPC section 5.1): Small-molecule RTK inhibitor that blocks the kinase activity of VEGFR1–3 and also FGFR1–4, PDGFRα, KIT and RET, suppressing proangiogenic and oncogenic signalling.

### Lenvima

- Company: Eisai GmbH
- Target: Multikinase inhibitor (VEGFR, FGFR, PDGFRα, KIT, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX08
- EU approval: 28 May 2015
- Label revised: 26 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/lenvima-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/lenvima

Mechanism (SmPC section 5.1): Small-molecule inhibitor of VEGFR1–3 kinases and other proangiogenic and oncogenic RTKs (FGFR1–4, PDGFRα, KIT, RET), blocking tumour angiogenesis and FGFR-driven proliferation.

## Label wording

- **Lenvatinib** (Kisplyx), Renal cell carcinoma, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf)
- **Lenvatinib** (Kisplyx), Renal cell carcinoma, 2nd line, advanced: “in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf)
- **Lenvatinib** (Lenvima), Thyroid cancer, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf)
- **Lenvatinib** (Lenvima), Hepatocellular carcinoma, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf)
- **Lenvatinib** (Lenvima), Endometrial cancer, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/lenvatinib