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Lenvima FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 18, 2019.

FDA Approved: Yes (First approved February 13, 2015)
Brand name: Lenvima
Generic name: lenvatinib
Dosage form: Capsules
Company: Eisai Inc.
Treatment for: Thyroid Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma, Endometrial Cancer

Lenvima (lenvatinib) is a multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and endometrial carcinoma.

Indications

  • Thyroid Cancer
    • for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
  • Renal Cell Carcinoma
    • in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy.
  • Hepatocellular Carcinoma
    • for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
  • Endometrial Carcinoma
    • in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

Development Timeline for Lenvima

DateArticle
Aug 11, 2021Approval  FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)
Jul 22, 2021Approval  FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
Sep 17, 2019Approval  FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma
Aug 16, 2018Approval  FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
May 13, 2016Approval  FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma
Feb 13, 2015Approval  FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer
Feb 12, 2015Lenvatinib Phase III Trial Results Published in New England Journal of Medicine
Jan 30, 2015Phase II Trial of Anticancer Agent Lenvatinib in Renal Cell Carcinoma Meets Primary Endpoint
Oct 15, 2014U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib

Further information

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