Lenvatinib
An oral anti-angiogenic pill that matched sorafenib in liver cancer with higher response rates, and partners with pembrolizumab in kidney and endometrial cancer.
REFLECT (2018): non-inferior OS (13.6 vs 12.3 months) with better PFS and ORR than sorafenib in first-line HCC. LEAP-002 (with pembrolizumab) missed its OS endpoint versus lenvatinib alone; LEAP-012 (with pembrolizumab plus TACE) improved PFS but not OS. Also approved in thyroid cancer, RCC (with everolimus or pembrolizumab) and endometrial cancer (with pembrolizumab). Hypertension, proteinuria and weight loss are dose-limiting.
1.Blocks VEGFR and FGFR on tumour vessels
- Route
- Oral
- Schedule
- 12 mg daily (≥60 kg) or 8 mg daily (<60 kg) in HCC
- Dose modifications
- Interrupt then reduce for grade 3 toxicity
- Monitoring
- Blood pressure, urine protein, thyroid function
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
- Assistance programmes
- Eisai Assistance Program
- Merck Access Program
- Merck Patient Assistance Program — Free medicine for eligible uninsured or underinsured patients.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- Untreated advanced HCC
- Notes
- Progressive radioactive iodine-refractory differentiated thyroid cancer: TA535 (2018). With pembrolizumab for endometrial cancer (TA904, 2023) and RCC (TA858, 2023).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA551 · SMC advice: lenvatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 17 Sept 2019ApprovalUS
Accelerated approval with pembrolizumab in endometrial cancer (KEYNOTE-146)
- 21 Jul 2021ApprovalUS
Full approval, pMMR endometrial cancer (KEYNOTE-775)
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Radioiodine-refractory thyroid cancer |
| US | 2018 | First-line unresectable HCC |
| US | 2021 | Advanced RCC with pembrolizumab; endometrial cancer with pembrolizumab |
| US | 2015 | Radioiodine-refractory differentiated thyroid cancer |
| US | 2016 | Advanced RCC with everolimus after anti-angiogenic therapy |
| US | 2021 | First-line advanced RCC with pembrolizumab (CLEAR); advanced endometrial cancer with pembrolizumab |
| US | 2018 | Unresectable HCC |
| US | 2021 | pMMR advanced endometrial cancer after platinum, with pembrolizumab; first-line RCC with pembrolizumab |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hypertension REFLECT | 42% | 23% |
| Diarrhoea REFLECT | 39% | 4% |
| Decreased appetite/weight loss REFLECT | 34% | 5% |
| Proteinuria REFLECT | 25% | 6% |
| Hypertension | 56% | — |
| Diarrhoea | 62% | — |
| Proteinuria | 30% | — |
| Weight loss | 30% | — |
| Grade 3+ any | — | 82% |
| Hypertension KEYNOTE-775 | 64% | 38% |
| Hypothyroidism | 57% | 1% |
| Diarrhoea | 54% | 8% |
| Weight loss | 34% | 10% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Lenvatinib" OR ABSTRACT:"Lenvatinib" OR TITLE:"Lenvima" OR ABSTRACT:"Lenvima") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lenvatinib, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductSorafenib
Shares REFLECT, Hand-foot syndrome and hand-foot skin reaction, Radioiodine therapy (I-131), The angiogenic switch & tumour vessels.
- ProductCabozantinib
Shares Hand-foot syndrome and hand-foot skin reaction, Anti-VEGF class toxicities (hypertension, proteinuria, bleeding, perforation), IMDC risk → first-line regimen choice (RCC), Tyrosine kinase inhibitor (TKI).
- ProductRegorafenib
Shares Hand-foot syndrome and hand-foot skin reaction, Anti-VEGF class toxicities (hypertension, proteinuria, bleeding, perforation), RET, KIT.
- PairingPD-1 blockade + VEGF inhibition
Shares Lenvatinib + pembrolizumab (pMMR endometrial cancer after platinum), Use imaging to find the window when tumour blood vessels are working properly, VEGF angiogenesis, Anti-angiogenic therapy.
- ProductSunitinib
Shares CLEAR (KEYNOTE-581), Thymoma and thymic carcinoma, KIT, The angiogenic switch & tumour vessels.
- ProductAxitinib
Shares IMDC risk → first-line regimen choice (RCC), The angiogenic switch & tumour vessels, Salivary gland cancers, Anti-angiogenic therapy.
- ProductPazopanib
Shares KIT, The angiogenic switch & tumour vessels, Anti-angiogenic therapy, VEGF / VEGFR.
- PairingTACE + immunotherapy/anti-VEGF
Shares LEAP-012, EMERALD-3, Anti-angiogenic therapy, Hepatocellular carcinoma.