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Lenvima (LENVATINIB)
Lenvima works by blocking the activity of a specific protein called Ret, which is involved in the growth and spread of cancer cells.
Lenvima (Lenvatinib) is a small molecule kinase inhibitor developed by Eisai Inc, targeting the proto-oncogene tyrosine-protein kinase receptor Ret. It is a FDA-approved treatment for various cancers, including endometrial carcinoma, follicular thyroid carcinoma, and renal cell carcinoma. Lenvima works by inhibiting the growth of cancer cells and reducing tumor size. As of now, it remains a patented product with no generic manufacturers. Key safety considerations include potential liver damage and hypertension.
At a glance
| Generic name | LENVATINIB |
|---|---|
| Sponsor | Eisai |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Proto-oncogene tyrosine-protein kinase receptor Ret |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2015 |
| Annual revenue | 1053 |
Mechanism of action
Lenvatinib is kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib inhibits other kinases 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; platelet derived growth factor receptor alpha (PDGFR), KIT, and RET. Lenvatinib also exhibited antiproliferative activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling with concurrent inhibition of FGF-receptor substrate (FRS2) phosphorylation. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.The combination of lenvatinib an
Approved indications
- Endometrial carcinoma progressing after chemotherapy
- Follicular thyroid carcinoma
- Hurthle cell carcinoma of thyroid
- Liver cell carcinoma
- Papillary thyroid carcinoma
- Renal cell carcinoma
- Thymic carcinoma
Common side effects
- Hypertension
- Fatigue
- Diarrhea
- Arthralgia/Myalgia
- Decreased Appetite
- Decreased Weight
- Nausea
- Stomatitis
- Headache
- Vomiting
- Proteinuria
- Palmar-Plantar Erythrodysesthesia Syndrome
Key clinical trials
- A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma (PHASE3)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (PHASE3)
- A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment (PHASE1,PHASE2)
- A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010) (PHASE3)
- Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) (PHASE2)
- Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (PHASE3)
- TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (PHASE2)
- Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lenvima CI brief — competitive landscape report
- Lenvima updates RSS · CI watch RSS
- Eisai portfolio CI