Lenvima (lenvatinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved May 2016

Specific Treatments:

advanced renal cell carcinoma

Therapeutic Areas

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General Information

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).

Lenvima is specifically indicated for use in combination with everolimus for the treatment of patients with advanced RCC following one prior anti-angiogenic therapy.

Lenvima is supplied as a capsule for oral administration. The recommended daily dose of Lenvima is 18 mg (one 10 mg capsule and two 4 mg capsules) in combination with 5 mg everolimus orally taken once daily with or without food. Continue Lenvima plus everolimus until disease progression or until unacceptable toxicity. Take Lenvima and everolimus 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. Lenvima capsules should be swallowed whole. Alternatively, the capsules can be dissolved in a small glass of liquid. Please see the drug label for specific instructions.

Clinical Results

FDA Approval

The FDA approval of Lenvima for renal cell carcinoma was based on a multicenter study which randomized 153 patients with advanced or metastatic renal cell carcinoma who had previously received anti-angiogenic therapy to Lenvima 18 mg plus everolimus 5 mg, Lenvima 24 mg monotherapy, or everolimus 10 mg monotherapy. All medications were administered orally once daily. The primary endpoint was investigator-assessed PFS evaluated according to RECIST 1.1. Lenvima and everolimus (LEN+EVE) resulted in a median PFS nearly three times that of everolimus alone. The median PFS, or the length of time from randomization until disease progression or death, in patients treated with the combination (n=51) was 14.6 months compared with 5.5 months for those treated with everolimus alone (n=50). The combination regimen resulted in a 63% reduction in the risk of disease progression or death compared with everolimus alone. The objective response rate was 37% in patients treated with the combination regimen (35% partial response + 2% complete response) compared to 6% (all partial response) in patients treated with everolimus alone. The patients who received LEN+EVE experienced a 10.1-month increase in median OS compared with those who received everolimus monotherapy (25.5 months) versus 15.4 months. This OS analysis was conducted when 63% of deaths had occurred in the combination arm and 74% of deaths had occurred in the everolimus arm.

Side Effects

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

  • diarrhea
  • fatigue
  • arthralgia/myalgia
  • decreased appetite
  • vomiting
  • nausea
  • stomatitis/oral inflammation
  • hypertension
  • peripheral edema
  • cough
  • abdominal pain
  • dyspnea
  • rash
  • weight decreased
  • hemorrhagic events
  • proteinuria

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.

Additional Information

For additional information regarding Lenvima or renal cell carcinoma, please visit http://www.lenvima.com/