LENVIMA (lenvatinib mesylate)
LENVIMA is indicated for the treatment of Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer; Advanced renal cell carcinoma (first-line, in combination with pembrolizumab); Advanced renal cell carcinoma following one prior anti-angiogenic therapy (in combination with everolimus); Unresectable hepatocellular carcinoma (first-line); Advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) following prior systemic therapy (in combination with pembrolizumab).
How LENVIMA Works
Lenvatinib inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, VEGFR2, and VEGFR3. It also targets other kinases implicated in pathogenic angiogenesis and tumor progression, including fibroblast growth factor (FGF) receptors, platelet-derived growth factor receptor alpha, KIT, and RET. By blocking these pathways, the drug inhibits endothelial cell proliferation and signaling necessary for tumor growth and blood vessel formation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-02-13
- PDUFA Date
- 2026-10-04 (131d)
- Patent Cliff
- 2038
- Revenue
- $255M (Q4-2024)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LENVIMA Approval History
What LENVIMA Treats
5 indicationsLENVIMA is approved for 5 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
- Advanced renal cell carcinoma (first-line, in combination with pembrolizumab)
- Advanced renal cell carcinoma following one prior anti-angiogenic therapy (in combination with everolimus)
- Unresectable hepatocellular carcinoma (first-line)
- Advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) following prior systemic therapy (in combination with pembrolizumab)
LENVIMA Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
LENVIMA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LENVIMA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LENVIMA treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
269 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06110793 | 23-274 | Ph 1, Ph 2 | recruiting | A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer |
| NCT07405164 | 6482-043 U1111-1325-4582, 2025-524160-38-00 | Ph 3 | recruiting | Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
| NCT03486873 | 3475-587 MK-3475-587, KEYNOTE-587 | Ph 3 | recruiting | Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) |
| NCT04938817 | 3475-B98 MK-3475-B98, KEYNOTE-B98 | Ph 1, Ph 2 | recruiting | Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) |
| NCT05903833 PIERCE | AGO-Vulva 1 2024-515646-16-00 | Ph 2 | recruiting | Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy |
| NCT07571551 TRIPLE-PATH | DZQH-KYLL-26-05 | Ph 2 | recruiting | Perioperative Trial With IO/TKI for Multi-stage Clear Cell Renal Cell Carcinoma |
| NCT04848337 PLANE-PC results posted | UMCC 2020.106 HCRN GU19-385, HUM00184431 | Ph 2 | active not recruiting | Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer |
| NCT04164199 | BGB-A317-290-LTE1 2019-002554-23, 2023-508883-31-00 | Ph 3 | active not recruiting | Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies |
| NCT04626518 | 3475-03B MK-3475-03B, KEYMAKER-U03 | Ph 1, Ph 2 | active not recruiting | Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) |
| NCT04626479 | 3475-03A MK-3475-03A, 2023-506838-68-00 | Ph 1, Ph 2 | active not recruiting | Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) |
| NCT04736706 | 6482-012 MK-6482-012, jRCT2031210435 | Ph 3 | active not recruiting | A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) |
| NCT06266338 | STU-2023-1118 | Ph 2 | recruiting | Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) |
| NCT04199104 results posted | 7902-010 MK-7902-010, LEAP-10 | Ph 3 | completed | 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) |
| NCT04586231 | 6482-011 MK-6482-011, jRCT2031210311 | Ph 3 | active not recruiting | A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) |
| NCT07014150 | QBA001 | Ph 2 | recruiting | Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma |
| NCT03797326 results posted | 7902-005 MK-7902-005, E7080-G000-224 | Ph 2 | completed | Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) |
| NCT05327686 SAMURAI | NRG-GU012 NCI-2022-02189, NRG-GU012 | Ph 2 | recruiting | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial |
| NCT05081180 | MS100070_0087 2020-004397-22, 2024-512940-51-00 | Ph 1 | active not recruiting | Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors |
| NCT05384015 PEERS | GECP 20/06_PEERS 2020-005230-15 | Ph 2 | active not recruiting | Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer |
| NCT04887805 | 21092 NCI-2021-03222, 21092 | Ph 2 | active not recruiting | Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer |
| NCT04662710 results posted | 7902-015 MK-7902-015, E7080-G000-321 | Ph 3 | completed | Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) |
| NCT07219459 GDFATHERHCC01 | CTL-002-005 2025-520675-86-00 | Ph 2 | recruiting | Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure |
| NCT06187961 CCGLC-011 | 2023-S039 | Ph 2 | active not recruiting | HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma |
| NCT05103904 | STUDY00003060 NCI-2021-07757, Winship5381-21 | Ph 2 | terminated | Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant |
| NCT04207086 Neo PeLe | MIA/CT2019/281 OTSP 57111 | Ph 2 | active not recruiting | A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma |
| NCT04246177 | 7902-012 MK-7902-012, LEAP-012 | Ph 3 | completed | Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) |
| NCT07328009 HCC-SIGHT | HCC-SIGHT | Ph 2 | recruiting | A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma |
| NCT04784247 | 21-047 | Ph 2 | active not recruiting | Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma |
| NCT04393350 results posted | STUDY00000009 NCI-2020-01064, Winship4955-20 | Ph 2 | active not recruiting | Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma |
| NCT05775159 | D7987C00001 | Ph 2 | recruiting | Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer |
| NCT07537946 | EXACT-EMH-HCC-011 | Ph 3 | not yet recruiting | Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer |
| NCT05064280 | 2021-0611 NCI-2021-11329 | Ph 2 | recruiting | Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases |
| NCT06669572 | IRB24-1542 | Ph 2 | recruiting | Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment |
| NCT06880523 SLIDE-HCC | HE2 | Ph 2 | recruiting | STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma |
| NCT06253494 | 10001557 001557-C | Ph 1, Ph 2 | recruiting | Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer |
| NCT07518706 | 2508012438 | Ph 2 | not yet recruiting | Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin |
| NCT05696548 | YCU18001 JapicCTI-194835 | Ph 2 | active not recruiting | Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION) |
| NCT04305054 | 3475-02B MK-3475-02B, KEYMAKER-U02 | Ph 1, Ph 2 | active not recruiting | Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) |
| NCT05301842 EMERALD-3 | D910VC00001 2023-508701-24-00, 2021-003822-54 | Ph 3 | active not recruiting | Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC |
| NCT04039607 CheckMate 9DW | CA209-9DW | Ph 3 | active not recruiting | A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma |
| NCT07487662 ACTION-001 | ACTION-001 IIT-2026-010 | Ph 2 | not yet recruiting | TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk |
| NCT07495579 REVIVE | KCSG HB25-15 HB25-15 | Ph 2 | not yet recruiting | Lenvatinib or Regorafenib for Advanced Hepatocellular Carcinoma After Immunotherapy (REVIVE) |
| NCT07493668 FLEX-HCC | 2026-02-022 | Ph 2 | not yet recruiting | Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy |
| NCT06858813 | M25-292 2024-518012-39, 2024-518012-39-00 | Ph 1 | recruiting | A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-324 in Adult Participants With Hepatocellular Cancer (HCC) or Squamous-Cell Non-Small Cell Lung Cancer (LUSC) |
| NCT04008797 | E7386-J081-102 2022-003300-32, 2023-510275-64-00 | Ph 1, Ph 2 | active not recruiting | A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor |
| NCT05319730 | 3475-06B jRCT2031220582, 2023-505189-26-00 | Ph 1, Ph 2 | recruiting | A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B) |
| NCT03517449 results posted | E7080-G000-309 2017-004387-35, MK3475-775 | Ph 3 | completed | Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) |
| NCT06036836 | 4280A-010 MK-4280A-010, 2023-505022-34-00 | Ph 2 | completed | Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) |
| NCT03950609 | 2018-0253 NCI-2019-02051, 2018-0253 | Ph 2 | active not recruiting | Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors |
| NCT04977453 | GII-101-P101 (MK-3475-B59) KEYNOTE-B59 | Ph 1, Ph 2 | recruiting | GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors |
Showing 50 of 269 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LENVIMA FDA Label Details
Indications & Usage
FDA Label (PDF)LENVIMA is indicated for the treatment of Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer; Advanced renal cell carcinoma (first-line, in combination with pembrolizumab); Advanced renal cell carcinoma following one prior anti-angiogenic therapy (in combination with everolimus); Unresectable hepatocellular carcinoma (first-line); Advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) following prior systemic therapy (in combination with pembrolizumab).
LENVIMA Patents & Exclusivity
Patents (20 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LENVIMA
Revenue Insights
- • Q4-2024: $255M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 84 active patents
Trial Analysis
- • 279 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment