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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

Development timeline for Lenvima

DateArticle
Oct  5, 2023Fostrox + Lenvima continues to show promising tumor control in Hepatocellular Carcinoma
Sep  4, 2023Medivir reports promising interim data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima
Oct 21, 2022Eisai Announces Real-World Evidence on the Clinical Effectiveness of Lenvima Monotherapy for the Treatment of Patients with Radioiodine-Refractory Differentiated Thyroid Cancer
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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