Drug · Small Molecule
Lenvatinib
CI-DRUG-00000336Explore in graph →NCIt C95124 CHEMBL1289601 CIViC Approved
Regulatory
Approvals (25)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Renal Cell Carcinoma | Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.accelerated | approved | Aug 25, 2016 | ema |
| EU EMA | — | Lenvima is indicated as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.accelerated | approved | May 28, 2015 | ema |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 16 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 168 | 79 | 58 | 370 | 25 | CA, EU, US | Feb 13, 2015 | 2005-07 |
| Malignant Liver Neoplasm | Approved | Phase 4 | 65 | 36 | 29 | 134 | 1 | US | Feb 13, 2015 | Jul 24, 2009 |
| Malignant Kidney Neoplasm | Approved | Phase 4 | 16 | 6 | 6 | 31 | 3 | EU, US | Feb 13, 2015 | Aug 5, 2010 |
| Malignant Uterine Corpus Neoplasm | Approved | Phase 3 | 7 | 3 | 1 | 11 |
Curated evidence
Clinical evidence (4)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-26
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 42158873
- Run
- ING-CIVIC-20260926-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| High1 | ||||||||
| Ipilimumab + Lenvatinib | ||||||||
Clinical trials
Trials with this intervention (389)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05273554 | A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma | completed | Phase 1 | 15 | M.D. Anderson Cancer CenterOTHER | 1 | Sep 29, 2026 | clinicaltrials |
| NCT07847359 | Cryoablation Combined With Hepatic Arterial Infusion of Iparomlimab and Tuvonralimab (QL1706), Intravenous Dacarbazine, and Oral Lenvatinib in Patients With Liver Metastases From Malignant Melanoma: a Single-arm, Phase II, Prospective Trial |