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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.
Oral inhibitor of VEGFR1-3, FGFR1-4, PDGFR-α, RET and KIT. Connects to VEGF / VEGFR, FGFR2, RET and KIT.
1.Blocks VEGFR and FGFR on tumour vessels
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).
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.
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.
Sources: NICE TA551 · SMC advice: lenvatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation
Accelerated approval with pembrolizumab in endometrial cancer (KEYNOTE-146)
In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation
Full approval, pMMR endometrial cancer (KEYNOTE-775)
With belzutifan, advanced renal cell carcinoma with a clear cell component source
| 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 | 2016 | Advanced RCC with everolimus after anti-angiogenic therapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hypertension | 42% | 23% |
| Diarrhoea | 39% | 4% |
| Decreased appetite/weight loss | 34% | 5% |
| Proteinuria | 25% | 6% |
REFLECT. 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.
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There has been no clear standard for clear-cell kidney cancer that progresses after immunotherapy; this is the first phase 3 to show a HIF-2 alpha inhibitor combination beating a standard tyrosine kinase inhibitor on progression-free survival in that setting. Whether it changes practice depends on the final overall survival analysis and on regulators, since the interim survival difference did not reach significance and the combination brings the toxicity of two drugs.
Lenvatinib-pembrolizumab with chemoembolisation is an emerging option for intermediate-stage disease, balanced against substantial toxicity.
Lenvatinib-pembrolizumab is the standard second-line treatment for mismatch repair-proficient endometrial cancer after platinum, though its toxicity is considerable and its place after first-line immunotherapy is unclear.
Lenvatinib is one of the few drugs with prospective evidence in thymic carcinoma after chemotherapy, alongside sunitinib and pembrolizumab.
Lenvatinib (like axitinib) is a guideline option for progressing adenoid cystic carcinoma; responses are uncommon, so it is reserved for documented progression rather than indolent disease.
Lenvatinib is a first-line alternative to sorafenib and the preferred kinase inhibitor when immunotherapy is contraindicated, such as after liver transplantation.
Lenvatinib is the first-choice kinase inhibitor for progressive iodine-refractory papillary and follicular thyroid cancer, reserved for symptomatic or rapidly progressing disease because of its toxicity.
Query 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.
Shares Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043), Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial, Anti-VEGF class toxicities (hypertension, proteinuria, bleeding, perforation), LITESPARK-011.
Shares LITESPARK-012, Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A), 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), Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043).
Shares REFLECT: lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma, Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Bu, REFLECT, Radioiodine therapy (I-131).
Shares A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer, IMDC risk → first-line regimen choice (RCC), Adenoid cystic carcinoma, Renal cell carcinoma (KEGG map).
Shares Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer., Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer, An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy., Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer.
Shares An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy., HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer, Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer, A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer.
Shares CLEAR (KEYNOTE-581), Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors, Chromophobe renal cell carcinoma, Renal cell carcinoma (KEGG map).
Shares Cryoablation Combined With QL1706 (Iparomlimab/Tuvonralimab) Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer., Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer, An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy., Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer.