Lenvatinib is used in several oncology settings, but approved indications differ by jurisdiction and may change as regulatory authorities review new evidence.
Differentiated thyroid cancer
In the United States, LENVIMA is indicated for adult patients with locally recurrent or metastatic, progressive, radioactive-iodine-refractory differentiated thyroid cancer.
The EMA similarly describes Lenvima as monotherapy for adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma that is refractory to radioactive iodine.
Renal cell carcinoma
U.S. labeling includes lenvatinib in combination with pembrolizumab as first-line treatment for adults with advanced renal cell carcinoma. It is also indicated with everolimus following one prior anti-angiogenic therapy.
In Europe, lenvatinib is marketed as Kisplyx for specified advanced renal-cell-carcinoma combinations rather than relying on the Lenvima indication wording.
Hepatocellular carcinoma
Current U.S. labeling identifies lenvatinib as a first-line treatment for unresectable hepatocellular carcinoma. The U.S. dose is weight-based.
The EMA describes Lenvima as monotherapy for adults with advanced or unresectable hepatocellular carcinoma who have not previously received systemic therapy.
Endometrial carcinoma
In the United States, LENVIMA is used with pembrolizumab for specified advanced endometrial carcinoma that is mismatch-repair proficient or not MSI-high, after prior systemic therapy, when curative surgery or radiation is not appropriate.
The European indication has different wording and applies to certain advanced or recurrent endometrial carcinoma following prior platinum-containing treatment where curative surgery or radiation is not possible.
Approved versus investigational use
The existence of clinical research involving lenvatinib does not establish an approved indication. Treatment decisions should be based on the applicable local authorization and professional clinical judgment.
Treatment combinations
Depending on the indication, lenvatinib may be used alone or in combination with pembrolizumab or everolimus. The combination partners, treatment line and dosing are indication-specific.