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DEB-TACE plus Lenvatinib
DEB-TACE plus Lenvatinib is a Combination therapy: locoregional chemotherapy + multi-kinase inhibitor Small molecule drug developed by Guangxi Medical University. It is currently in Phase 3 development for Hepatocellular carcinoma (HCC), intermediate to advanced stage.
DEB-TACE delivers doxorubicin directly to hepatocellular carcinoma via drug-eluting beads, while lenvatinib inhibits multiple receptor tyrosine kinases to suppress tumor angiogenesis and growth.
DEB-TACE delivers doxorubicin directly to hepatocellular carcinoma via drug-eluting beads, while lenvatinib inhibits multiple receptor tyrosine kinases to suppress tumor angiogenesis and growth. Used for Hepatocellular carcinoma (HCC), intermediate to advanced stage.
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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 | DEB-TACE plus Lenvatinib |
|---|---|
| Sponsor | Guangxi Medical University |
| Drug class | Combination therapy: locoregional chemotherapy + multi-kinase inhibitor |
| Target | DEB-TACE: topoisomerase II (doxorubicin); Lenvatinib: FGFR, VEGFR, RET, KIT, PDGFR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
DEB-TACE (drug-eluting bead transarterial chemoembolization) is a locoregional therapy that uses microspheres loaded with doxorubicin to deliver high drug concentrations directly to liver tumors while occluding blood supply. Lenvatinib is a multi-kinase inhibitor targeting FGFR, VEGFR, RET, and other pathways to inhibit angiogenesis and tumor proliferation. The combination aims to enhance efficacy through local chemotherapy plus systemic anti-angiogenic activity.
Approved indications
- Hepatocellular carcinoma (HCC), intermediate to advanced stage
Common side effects
- Hepatic toxicity / elevated liver enzymes
- Hypertension
- Diarrhea
- Fatigue
- Nausea / vomiting
- Hand-foot skin reaction
Key clinical trials
- ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC (PHASE2)
- A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data
- Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT (PHASE2)
- Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT (PHASE3)
- Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC (PHASE3)
- Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT
- Survival Analysis: TACE vs. Combination Therapy in HCC
- DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma
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:
- DEB-TACE plus Lenvatinib CI brief — competitive landscape report
- DEB-TACE plus Lenvatinib updates RSS · CI watch RSS
- Guangxi Medical University portfolio CI
Frequently asked questions about DEB-TACE plus Lenvatinib
What is DEB-TACE plus Lenvatinib?
How does DEB-TACE plus Lenvatinib work?
What is DEB-TACE plus Lenvatinib used for?
Who makes DEB-TACE plus Lenvatinib?
What drug class is DEB-TACE plus Lenvatinib in?
What development phase is DEB-TACE plus Lenvatinib in?
What are the side effects of DEB-TACE plus Lenvatinib?
What does DEB-TACE plus Lenvatinib target?
Related
- Drug class: All Combination therapy: locoregional chemotherapy + multi-kinase inhibitor drugs
- Target: All drugs targeting DEB-TACE: topoisomerase II (doxorubicin); Lenvatinib: FGFR, VEGFR, RET, KIT, PDGFR
- Manufacturer: Guangxi Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hepatocellular carcinoma (HCC), intermediate to advanced stage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing