General Information

Lenvima (lenvatinib) is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, as well as other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions.

Lenvima is specifically indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Lenvima is supplied as a capsule for oral administration. The recommended daily dose of Lenvima is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily with or without food. Lenvima should be taken at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration. For dose modifications in specific patients, please see drug label. Lenvima should be administered until disease progression or until unacceptable toxicity occurs.

Clinical Results

FDA Approval

The FDA approval of Lenvima was based on a multicenter, randomized, double-blind, placebo-controlled trial in 392 subjects with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within 12 months prior to randomization, confirmed by independent radiologic review. The subjects received Lenvima 24 mg once daily (n=261) or placebo (n=131) until disease progression. Study results showed Lenvima-treated subjects lived a median of 18.3 months without their disease progressing (progression-free survival), compared to a median of 3.6 months for subjects who received placebo. Additionally, 65% of subjects treated with Lenvima saw a reduction in tumor size, compared to 2% of subjects who received a placebo.

Side Effects

Adverse effects associated with the use of Lenvima may include, but are not limited to, the following:

hypertension

fatigue

diarrhea

arthralgia/myalgia

decreased appetite

weight decreased

nausea

stomatitis

headache

vomiting

proteinuria

palmar-plantar erythrodysesthesia syndrome

abdominal pain

dysphonia

Mechanism of Action

Lenvima (lenvatinib) is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.