Drug

Lenvatinib (Lenvima)

An oral multi-kinase inhibitor for thyroid, liver, kidney and endometrial cancer

Updated: 27 October 20269 min read8 references
Generic name
Lenvatinib
Brand names
Lenvima
Drug class
Multi-kinase inhibitor (VEGFR, FGFR, PDGFRα, KIT and RET)
Route
Oral capsule
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Key points

  • Lenvatinib is a targeted capsule that stops tumours from making new blood vessels and blocks several growth signals [1].
  • It is used on its own for thyroid cancer that no longer responds to radioactive iodine and for liver cancer, and with other drugs for kidney and womb cancer [1].
  • In thyroid cancer it kept the disease under control several times longer; in liver cancer it helped patients live at least as long as the previous drug (sorafenib) [2, 3].
  • The most common important side effect is high blood pressure; tiredness, diarrhoea, poor appetite, weight loss and protein in the urine are also common [1].
  • Take it once a day, at the same time each day, with or without food; if you miss a dose and more than 12 hours have passed, skip that dose [1].
For physicians

What is this drug and how does it work?

For physiciansLenvatinib
For physicians

Lenvatinib (brand name Lenvima) is an oral targeted drug from the group of kinase inhibitors [1]. It inhibits the kinase activity of vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), which are involved in forming the new blood vessels tumours need to grow (angiogenesis) [1].

Lenvatinib also inhibits other kinases involved in angiogenesis, tumour growth and cancer progression, including fibroblast growth factor receptors (FGFR1 to FGFR4), PDGFRα, KIT and RET [1]. In animal models, lenvatinib reduced tumour-associated macrophages and increased activated cytotoxic T cells, and with an anti-PD-1 antibody had greater antitumour activity than either alone; this finding supports its combination with pembrolizumab (Keytruda) [1].

Which cancers is it used for?

According to the FDA label, lenvatinib is used in thyroid cancer, hepatocellular carcinoma (liver cancer), kidney cancer and endometrial cancer [1]. In endometrial cancer, patients are selected by MMR or MSI testing of a tumour sample [1]. Approvals may differ between countries, and not every patient with these cancers is a candidate for this drug.

For patients
What is this drug for?

Your doctor may prescribe this drug for:

  • Differentiated thyroid cancer (DTC) [1, 2]
  • Hepatocellular carcinoma [1, 3]
  • Advanced kidney cancer (RCC) [1, 4]
  • Advanced kidney cancer [1, 5]
  • Advanced kidney cancer with a clear cell component [1]
  • Advanced endometrial cancer (pMMR or not MSI-H) [1, 6]
  • Hepatocellular carcinoma that has not spread but cannot be removed by surgery (not approved/under study) [7]

Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.

For physiciansApproved uses (FDA label) and key evidence · Place in liver cancer
For physicians
Approved uses (FDA label) and key evidence
CancerConditions of useKey evidence
Differentiated thyroid cancer (DTC)Adults with locally recurrent or metastatic, progressive, radioactive iodine-refractory disease; monotherapy [1]SELECT trial: median progression-free survival 18.3 vs 3.6 months with placebo (HR 0.21) [1, 2]
Hepatocellular carcinomaFirst-line treatment of unresectable disease; monotherapy [1]REFLECT trial: median overall survival 13.6 vs 12.3 months with sorafenib (non-inferior; HR 0.92) [1, 3]
Advanced kidney cancer (RCC)First-line treatment in adults, with pembrolizumab [1]CLEAR trial: median progression-free survival 23.9 vs 9.2 months with sunitinib (HR 0.39) [1, 4]
Advanced kidney cancerAdults after one prior anti-angiogenic therapy, with everolimus [1]Study 205: median progression-free survival 14.6 vs 5.5 months with everolimus alone [1, 5]
Advanced kidney cancer with a clear cell componentAdults after a PD-1 or PD-L1 inhibitor, with belzutifan [1]LITESPARK-011 trial: median progression-free survival 14.6 vs 10.6 months with cabozantinib (HR 0.74) [1]
Advanced endometrial cancer (pMMR or not MSI-H)Progression after prior systemic therapy and not a candidate for curative surgery or radiotherapy; with pembrolizumab [1]Study 309 (KEYNOTE-775): median overall survival 17.4 vs 12.0 months with chemotherapy (HR 0.68) [1, 6]
Unresectable non-metastatic hepatocellular carcinoma (not approved/under study)With transarterial chemoembolisation (TACE) and pembrolizumabLEAP-012 trial: median progression-free survival 14.6 vs 10.0 months; overall survival did not differ significantly at the interim analysis [7]

The last row is not an approved use. In the kidney and endometrial indications, the FDA label covers combination with pembrolizumab or pembrolizumab with berahyaluronidase alfa (the subcutaneous form) [1].

For physicians

Place in liver cancer: in the CheckMate 9DW trial, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as first-line treatment of hepatocellular carcinoma gave longer overall survival than lenvatinib or sorafenib (investigator's choice) (median 23.7 vs 20.6 months; HR 0.79) [8].

How it is taken and dosing

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Treatment regimens and doses: index6 regimens
For patients

Lenvatinib comes as capsules taken once a day, at the same time each day, with or without food [1]. Swallow the capsules whole; do not crush or chew them [1].

Tests and checks needed according to the label:

  • Blood pressure: must be controlled before starting; it is measured after 1 week, then every 2 weeks for the first 2 months and then at least monthly [1].
  • Liver tests: before starting, every 2 weeks for the first 2 months and then at least monthly [1].
  • Urine protein before starting and regularly, thyroid function before starting and at least monthly, and blood calcium at least monthly [1].
  • A heart scan (echocardiogram) and a dental check may be done before starting; women who could become pregnant need a pregnancy test [1].
  • The drug is stopped at least 1 week before planned surgery or dental surgery and not restarted until at least 2 weeks after major surgery and until the wound has healed well [1].
For physicians
Prescribing notes
  • Before starting: controlled blood pressure; liver tests, urine protein, thyroid function and calcium; consider a baseline LVEF assessment; oral and dental examination (risk of osteonecrosis of the jaw); correct electrolytes; confirm pregnancy status. In endometrial cancer, determine MMR/MSI status [1].
  • Dose modification: grade 3 hypertension despite optimal treatment: withhold and, once controlled at grade 2 or less, resume at a lower dose; grade 4: discontinue permanently. Grade 3 cardiac dysfunction: withhold until LVEF improves; grade 4: discontinue. Grade 3 to 4 hepatotoxicity or renal toxicity: withhold until grade 0 to 1, then a lower dose or discontinue; hepatic failure: discontinue. Proteinuria 2 g or more per 24 hours: withhold until 2 g or less, then a lower dose; nephrotic syndrome: discontinue. QTc above 500 ms or an increase of 60 ms or more: withhold until 480 or baseline, then a lower dose. Arterial thromboembolism or gastrointestinal perforation (any grade) and grade 3 to 4 fistula: discontinue permanently. RPLS: withhold until fully resolved. Other persistent or intolerable grade 2 to 3 adverse reactions or grade 4 laboratory abnormalities: withhold and resume at a lower dose; grade 4 adverse reaction: discontinue [1]. With pembrolizumab, modify one or both drugs [1].
  • Kidney and liver: severe renal impairment (creatinine clearance below 30 mL/min, Cockcroft-Gault with actual weight) or hepatic impairment (Child-Pugh C): thyroid 14 mg, RCC and endometrial 10 mg once daily. HCC: Child-Pugh A no adjustment; no recommended dose for Child-Pugh B or C or severe renal impairment. Mild and moderate renal impairment: no adjustment [1].
  • Surgery: stop at least 1 week before planned surgery and do not restart until at least 2 weeks after major surgery and adequate wound healing [1].
  • Monitoring: blood pressure after 1 week, then every 2 weeks for the first 2 months and then at least monthly; liver tests every 2 weeks for the first 2 months and then at least monthly; urine protein periodically; calcium at least monthly; thyroid function monthly; ECG and electrolytes in patients at high risk of QT prolongation; symptoms of heart failure [1].
For physiciansStandard dosing (FDA label, revised 09/2026), 6 regimens
For physicians

Standard dosing (FDA label, revised 09/2026)

Radioactive iodine-refractory differentiated thyroid cancer

Locally recurrent or metastatic, progressiveCycle length: Continuous

Locally recurrent or metastatic, progressive [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
Lenvatinib24 mgOral (with or without food)Once daily, at the same time every day
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity [1]

Dose reduction levels: 20, 14, 10 mg [1].

Unresectable hepatocellular carcinoma

First lineCycle length: Continuous

First line [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
LenvatinibActual body weight 60 kg or more: 12 mg; below 60 kg: 8 mgOral (with or without food)Once daily, at the same time every day
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity [1]

Dose reduction levels: 60 kg or more: 8, 4, then 4 mg every other day; below 60 kg: 4, 4 mg every other day, then discontinue [1].

Advanced RCC, first line (with pembrolizumab, CLEAR regimen)

AdultsCycle length: Continuous

Adults [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
Lenvatinib20 mgOral (with or without food)Once daily, at the same time every day
Up to 24 months
Pembrolizumab200 mg every 3 weeks (in CLEAR) or 400 mg every 6 weeks (in KEYNOTE-B61)IVAs per the pembrolizumab label
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity; after 2 years of combination treatment, lenvatinib may continue alone [1]

RCC dose reduction levels: 14, 10, 8 mg [1].

Advanced RCC after one anti-angiogenic therapy (with everolimus)

AdultsCycle length: Continuous

Adults [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
Lenvatinib18 mgOral (with or without food)Once daily, at the same time every day
Everolimus5 mgOralOnce daily
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity [1]

For shared toxicities, reduce or interrupt lenvatinib first and then everolimus [1].

Advanced RCC with a clear cell component after a PD-1/PD-L1 inhibitor (with belzutifan)

AdultsCycle length: Continuous

Adults [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
Lenvatinib20 mgOral (with or without food)Once daily, at the same time every day
Belzutifan120 mg (trial dose)OralOnce daily
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity [1]

Advanced pMMR or non-MSI-H endometrial carcinoma (with pembrolizumab)

Progression after prior systemic therapy and not a candidate for curative surgery or radiotherapyCycle length: Continuous

Progression after prior systemic therapy and not a candidate for curative surgery or radiotherapy [1]

Before prescribing: Prescribing notes
DrugDoseRouteSchedule
Continuous
Lenvatinib20 mgOral (with or without food)Once daily, at the same time every day
Up to 24 months
Pembrolizumab200 mg every 3 weeks (trial dose)IVAs per the pembrolizumab label
Cycle length
Continuous
Duration
Until progression or unacceptable toxicity [1]

Dose reduction levels: 14, 10, 8 mg [1].

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Side effects

Common side effects

For patients

The most common side effects:

  • High blood pressure in most patients; check your blood pressure regularly [1].
  • Tiredness, diarrhoea, poor appetite and weight loss, nausea [1].
  • Joint and muscle pain, mouth sores, a hoarse voice and hand-foot syndrome (red, sore palms and soles) [1].
  • Protein in the urine and an underactive thyroid; regular urine and thyroid tests are needed [1].
  • Many patients need a lower dose; this is normal [1].
For physiciansSpecialist notes · Common adverse reactions to lenvatinib in the main trials (all grades, FDA label)
For physicians

Lenvatinib's adverse reactions mostly reflect inhibition of angiogenesis and include hypertension, fatigue, diarrhoea, decreased appetite and weight, and proteinuria, and many patients need dose reductions; in SELECT, adverse reactions led to dose reduction in 68% of patients and discontinuation in 18% [1]. The table below shows the frequency of adverse reactions (all grades) in the three main trials.

For physicians
Common adverse reactions to lenvatinib in the main trials (all grades, FDA label) [1]
Adverse reactionSELECT – thyroid, 24 mgREFLECT – liver, 8 or 12 mgCLEAR – kidney, with pembrolizumab
Hypertension73%45%56%
Fatigue67%44%63%
Diarrhoea67%39%62%
Arthralgia/myalgia62%31%58% (musculoskeletal pain)
Decreased appetite54%34%41%
Weight loss51%31%30%
Nausea47%20%36%
Stomatitis41%11%43%
Proteinuria34%26%30%
Hand-foot syndrome (red, sore palms and soles)32%27%29%
Dysphonia31%24%30%
HypothyroidismNot reported in the table21%57%

The comparator was sorafenib in REFLECT and sunitinib in CLEAR; some of these reactions were also common in the comparator arms [1].

Serious side effects

For patients

These are less common but serious; tell your team early if you notice any sign of them:

  • Very high blood pressure, or a severe headache with confusion and blurred vision [1].
  • Heart problems, heart attack or stroke: chest pain, shortness of breath, weakness on one side of the body [1].
  • Liver damage: yellowing, confusion or sleepiness (especially in liver cancer) [1].
  • Kidney damage and severe diarrhoea with dehydration [1].
  • Bleeding (nosebleeds, blood in the urine or black stools), a hole in the bowel (severe abdominal pain) [1].
  • Slow wound healing, damage to the jaw bone and harm to an unborn baby [1].
For physiciansHypertension
For physicians

The FDA label for lenvatinib has no boxed warning but lists these important warnings [1]:

  • Hypertension: grade 3 in 44% of SELECT and 24% of REFLECT patients; serious complications of uncontrolled hypertension have been reported [1].
  • Cardiac dysfunction: serious and fatal heart failure and cardiomyopathy can occur; grade 3 or higher in 1% of 799 patients and in 6% of patients receiving the combination with belzutifan [1].
  • Arterial thromboembolism (myocardial infarction or stroke): 2% to 5% in the monotherapy and everolimus combination trials; 5% with pembrolizumab in CLEAR (myocardial infarction 3.4% and stroke 2.3%) [1].
  • Hepatotoxicity: in 1327 patients without liver cancer, serious hepatic adverse reactions in 1.4% and fatal in 0.5%; in REFLECT, hepatic encephalopathy in 8% (vs 3% with sorafenib) and grade 3 to 5 hepatic failure in 3% [1].
  • Renal impairment and proteinuria: renal impairment in 14% (SELECT) and 7% (REFLECT), including fatal cases; grade 3 proteinuria in 11% and 6% [1].
  • Diarrhoea: in 49% of 737 SELECT and REFLECT patients (grade 3 in 6%) [1].
  • Gastrointestinal fistula or perforation: in 2% of 799 patients [1].
  • QTc prolongation: 9% in SELECT (above 500 ms in 2%) [1].
  • Hypocalcaemia: grade 3 to 4 in 9% of SELECT patients [1].
  • Reversible posterior leucoencephalopathy syndrome (RPLS): 0.3% of 1823 patients [1].
  • Haemorrhage: in 29% of 799 patients (mostly epistaxis and haematuria); in REFLECT, grade 3 to 5 haemorrhage in 5%, including 7 fatal cases. Severe carotid artery haemorrhage has been seen more often in anaplastic thyroid cancer [1].
  • Thyroid dysfunction: raised TSH and hypothyroidism; monthly monitoring needed [1].
  • Impaired wound healing and osteonecrosis of the jaw [1].
  • Embryo-fetal toxicity: lenvatinib can harm a fetus [1].

When should I call my doctor?

Contact your treatment team straight away if you have these symptoms:

  • High blood pressure on home readings [1]
  • Shortness of breath, swollen ankles, unusual weight gain, chest pain or feeling faint (signs of a heart problem) [1]
  • Yellow skin or whites of the eyes, dark urine, pale stools, nausea or vomiting, pain in the upper right abdomen, sleepiness or confusion [1]
  • A change in the amount or colour of your urine, blood in the urine, swollen legs [1]
  • Diarrhoea that cannot be controlled or being unable to drink enough fluids [1]
  • A severe or prolonged nosebleed, vomiting blood, red or black tarry stools, coughing up blood, or new or heavy vaginal bleeding [1]
  • A severe headache, seizures, weakness, confusion or a change in vision [1]
  • Jaw pain, toothache or sores on the gums [1]

Severe chest pain or pressure, pain in the arm, back, neck or jaw, numbness or weakness on one side of the body, trouble speaking, a sudden severe headache, a sudden change in vision or severe abdominal pain need urgent help [1]; in these cases call your local emergency number.

Interactions, pregnancy and precautions

  • Drug interactions: avoid using it with drugs that prolong the QT/QTc interval [1]. Antifungal drugs such as ketoconazole and the antibiotic rifampicin change lenvatinib levels only slightly [1]. Give your treatment team a list of all your medicines and supplements.
  • Missing a dose: if you forget a dose and cannot take it within 12 hours, skip it and take the next dose at the usual time [1].
  • Pregnancy and contraception: a pregnancy test is done before starting; women who could become pregnant should use effective contraception during treatment and for 30 days after the last dose; with combination treatment, the longest period recommended in the partner drugs' labels applies [1].
  • Breastfeeding: do not breastfeed during treatment and for 1 week after the last dose (with combination treatment, the longest period recommended for the partner drugs) [1].
  • Fertility: lenvatinib may reduce fertility in women and men [1].
  • Teeth and surgery: keep up good oral hygiene, tell your dentist you take lenvatinib, and avoid invasive dental procedures during treatment where possible [1].
  • Older adults: in REFLECT, patients aged 75 and over tolerated lenvatinib less well [1].
  • Vaccines: the FDA label gives no specific advice about vaccines; talk to your treatment team before any vaccination.

Frequently asked questions

Is lenvatinib chemotherapy?

No. Lenvatinib is an oral targeted drug from the kinase inhibitor group that blocks receptors involved in blood vessel growth and tumour growth [1].

What if I cannot swallow the capsule?

Do not crush or chew the capsule. According to the label, the capsules can be dissolved in a small amount of water or apple juice and drunk, or given with water through a feeding tube; ask your pharmacist or treatment team for the exact method [1].

Why do I have to check my blood pressure regularly?

High blood pressure is the most common important side effect of lenvatinib (in about half to three quarters of patients) and usually appears in the first 3 to 4 weeks [1].

Does lenvatinib cause hair loss?

Hair loss is uncommon; about one in 8 patients has it [1].

How long does treatment last?

It continues as long as the disease does not progress and side effects are tolerable; your doctor may pause the drug or lower the dose to manage side effects [1].

Scientific evidence

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Key studies

5 items
Clinical trial · Phase 3

Lenvatinib versus placebo in radioiodine-refractory thyroid cancer

N Engl J Med · 2015
18.3 months vs 3.6 monthsMedian progression-free survival
Clinical trial · Phase 3

Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial

Lancet · 2018
13.6 vs 12.3 monthsMedian overall survival
Clinical trial · Phase 3

Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study

Lancet · 2025
14.6 vs 10.0 monthsMedian progression-free survival
Clinical trial · Phase 3

Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial

Lancet · 2025
23.7 vs 20.6 monthsMedian overall survival
Clinical trial · Phase 3

Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma

N Engl J Med · 2021
23.9 vs 9.2 monthsMedian progression-free survival (lenvatinib + pembrolizumab)

References

8 references
Show all references, 7 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    LENVIMA (lenvatinib) capsules, for oral use: Prescribing InformationEisai Inc · DailyMed, U.S. National Library of Medicine · 2026
  2. 2
    Lenvatinib versus placebo in radioiodine-refractory thyroid cancerSchlumberger M, Tahara M, Wirth LJ, et al · N Engl J Med · 2015;372:621-630
    Study cardDOIPubMed Back to text: 1 2 3
  3. 3
    Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trialKudo M, Finn RS, Qin S, et al · Lancet · 2018;391:1163-1173
    Study cardDOIPubMed Back to text: 1 2 3
  4. 4
    Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell CarcinomaMotzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, et al · N Engl J Med · 2021;384:1289-1300
    Study cardDOIPubMed Back to text: 1 2
  5. 5
    Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trialMotzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, et al · Lancet Oncol · 2015;16:1473-1482
    Study cardDOIPubMed Back to text: 1 2
  6. 6
    Lenvatinib plus Pembrolizumab for Advanced Endometrial CancerMakker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, et al · N Engl J Med · 2022;386:437-448
    Study cardDOIPubMed Back to text: 1 2
  7. 7
    Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 studyKudo M, Ren Z, Guo Y, et al · Lancet · 2025;405:203-215
    Study cardDOIPubMed Back to text: 1 2
  8. 8
    Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trialYau T, Galle PR, Decaens T, et al · Lancet · 2025;405:1851-1864

This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.