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
| Date | Article |
|---|
| Oct 5, 2023 | Fostrox + Lenvima continues to show promising tumor control in Hepatocellular Carcinoma |
| Sep 4, 2023 | Medivir reports promising interim data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima |
| Oct 21, 2022 | Eisai Announces Real-World Evidence on the Clinical Effectiveness of Lenvima Monotherapy for the Treatment of Patients with Radioiodine-Refractory Differentiated Thyroid Cancer |
| Aug 11, 2021 | Approval FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC) |
| Jul 22, 2021 | Approval FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma |
| Sep 17, 2019 | Approval FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma |
| Aug 16, 2018 | Approval FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC) |
| May 13, 2016 | Approval FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma |
| Feb 13, 2015 | Approval FDA Approves Lenvima (lenvatinib) for Differentiated Thyroid Cancer |
| Feb 12, 2015 | Lenvatinib Phase III Trial Results Published in New England Journal of Medicine |
| Jan 30, 2015 | Phase II Trial of Anticancer Agent Lenvatinib in Renal Cell Carcinoma Meets Primary Endpoint |
| Oct 15, 2014 | U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
