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Lenvatinib plus TACE
Lenvatinib plus TACE is a Multi-targeted tyrosine kinase inhibitor (in combination with transarterial chemoembolization) Small molecule drug developed by Second Affiliated Hospital of Guangzhou Medical University. It is currently in Phase 3 development for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization.
Lenvatinib inhibits multiple receptor tyrosine kinases to suppress tumor angiogenesis and growth, combined with TACE (transarterial chemoembolization) to deliver chemotherapy directly to hepatic tumors.
Lenvatinib is a small molecule used in combination with Transarterial chemoembolization (TACE) for the treatment of unresectable advanced Hepatocellular Carcinoma (HCC). This combination treatment is being studied in clinical trials, such as NCT04599790, for its efficacy in treating HCC conditions including non-resectable HCC and portal vein tumor thrombus.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Lenvatinib plus TACE |
|---|---|
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Drug class | Multi-targeted tyrosine kinase inhibitor (in combination with transarterial chemoembolization) |
| Target | FGFR, VEGFR, RET, KIT, and other receptor tyrosine kinases |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lenvatinib is a multi-targeted tyrosine kinase inhibitor that blocks FGFR, VEGFR, RET, and other kinases involved in tumor angiogenesis and proliferation. When combined with TACE—a minimally invasive procedure that delivers chemotherapy directly into the hepatic artery feeding the tumor while blocking blood supply—the two modalities work synergistically to enhance local tumor control and systemic anti-angiogenic effects in hepatocellular carcinoma.
Approved indications
- Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization
Common side effects
- Hypertension
- Diarrhea
- Fatigue
- Decreased appetite
- Nausea
- Proteinuria
- Weight loss
- Hepatotoxicity
Key clinical trials
- TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (PHASE2)
- Safety and Efficacy of LVD + C-TACE + Tis/Len for Unresectable Right-Liver HCC (NA)
- CECT Features of MVI Predict Response to TACE Plus TKI in Intermediate-stage HCC
- Construction and Clinical Validation of a Predictive Model for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Based on Whole-Slide Digital Pathological Images and Deep Learning (NA)
- Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma (NA)
- TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension (PHASE2)
- TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma
- 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) (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lenvatinib plus TACE CI brief — competitive landscape report
- Lenvatinib plus TACE updates RSS · CI watch RSS
- Second Affiliated Hospital of Guangzhou Medical University portfolio CI
Frequently asked questions about Lenvatinib plus TACE
What is Lenvatinib plus TACE?
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What is Lenvatinib plus TACE used for?
Who makes Lenvatinib plus TACE?
What drug class is Lenvatinib plus TACE in?
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What does Lenvatinib plus TACE target?
Related
- Drug class: All Multi-targeted tyrosine kinase inhibitor (in combination with transarterial chemoembolization) drugs
- Target: All drugs targeting FGFR, VEGFR, RET, KIT, and other receptor tyrosine kinases
- Manufacturer: Second Affiliated Hospital of Guangzhou Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing