Indications of Lenvatinib

This product is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy, as well as for the treatment of radioactive iodine-refractory differentiated thyroid carcinoma (DTC).

Differentiated Thyroid Carcinoma

It is indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine (Iodine-131)-refractory differentiated thyroid carcinoma (it has been designated an orphan drug for this cancer by the U.S. Food and Drug Administration (FDA)).

Renal Cell Carcinoma

Combined with pembrolizumab, it is used for the first-line treatment of advanced renal cell carcinoma (RCC).

Combined with everolimus, it is used for the treatment of patients with advanced renal cell carcinoma who have previously received anti-angiogenic drug therapy.

For patients with intermediate- or high-risk metastatic renal cell carcinoma requiring first-line systemic therapy, the American Society of Clinical Oncology (ASCO) recommends the following two combination treatment regimens: first, the combination of two immune checkpoint inhibitors (i.e., ipilimumab plus nivolumab); second, the combination of an immune checkpoint inhibitor and a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (e.g., pembrolizumab plus axitinib, nivolumab plus cabozantinib, avelumab plus axitinib, pembrolizumab plus lenvatinib). For patients with low-risk metastatic renal cell carcinoma requiring systemic therapy, the combination regimen of an immune checkpoint inhibitor and a VEGFR tyrosine kinase inhibitor may be adopted.

Hepatocellular Carcinoma

It is indicated for the first-line treatment of unresectable hepatocellular carcinoma (HCC) (it has been designated an orphan drug for this cancer by the U.S. Food and Drug Administration (FDA)).

The ASCO guidelines state that for patients with advanced hepatocellular carcinoma, Child-Pugh Class A liver function, and Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, if treatment with atezolizumab plus bevacizumab or durvalumab plus tremelimumab is not feasible, lenvatinib may be used as a first-line treatment agent.

ASCO also points out that tyrosine kinase inhibitors (i.e., cabozantinib, lenvatinib, regorafenib, sorafenib) can be used as second-line treatment agents following therapy with atezolizumab plus bevacizumab or durvalumab plus tremelimumab (off-label use).

The guideline recommendations issued by the American Gastroenterological Association (AGA) and the American Association for the Study of Liver Diseases (AASLD) are basically consistent with those of ASCO.

Endometrial Carcinoma

Combined with pembrolizumab, it is indicated for the treatment of patients with advanced endometrial carcinoma that has progressed after prior systemic therapy and is not amenable to curative surgery or radiotherapy, confirmed to be proficient mismatch repair (pMMR) or non-microsatellite instability-high (MSI-H) by FDA-approved testing methods.

Some international experts recommend the pembrolizumab plus lenvatinib regimen as the second-line treatment for patients with advanced or recurrent endometrial carcinoma that is proficient mismatch repair (pMMR) or microsatellite stable (MSS).

from FDA，2024.06