Lenvatinib

(Lenvima®)

Lenvatinib

Drug updated on 5/17/2024

Dosage FormCapsule (oral; 4 mg, 10 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
  • Indicated in combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC).
  • Indicated in combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
  • Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
  • Indicated in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Summary
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  • Lenvatinib (Lenvima) demonstrates significant efficacy in treating radioiodine-refractory differentiated thyroid cancer, offering a notable improvement in progression-free survival compared to placebo and several tyrosine kinase inhibitors. However, it also has a higher incidence of grade 3 or above adverse events.
  • A total of 86 systematic reviews/meta-analyses were reviewed for a summary on lenvatinib's therapeutic benefits, safety profile, and comparative effectiveness against other drugs across various cancer indications.
  • In comparison studies with sorafenib for the treatment of differentiated thyroid cancer, lenvatinib might outperform sorafenib in terms of progression-free survival rate, objective response rate (ORR), and disease control rate, but both drugs require dose modifications due to their toxic profiles.
  • For advanced renal cell carcinoma treatment following one prior anti-angiogenic therapy, lenvatinib used as monotherapy or combined with everolimus or pembrolizumab shows promising results. It improved overall survival notably when combined with pembrolizumab, indicating its potential as a preferred first-line treatment for RCC.
  • As a first-line therapy for unresectable hepatocellular carcinoma, lenvatinib shows comparable or superior efficacy in terms of survival outcomes when compared to sorafenib and the combination of atezolizumab plus bevacizumab. Despite its efficacy, careful consideration must be given to manage its adverse event profile, which includes hypertension and diarrhea among others.
  • In patients suffering from advanced endometrial carcinoma not amendable by surgery or radiation and progressing after systemic therapy, combining Lenvima (lenvatinib) with pembrolizumab showed remarkable efficiency, improving PFS and OS significantly, while presenting manageable toxicity levels, hinting at a valuable therapeutic option.
  • Across multiple cancer types including RAIR-DTC, RCC, HCC, and EC, lenvatinib’s safety profile necessitates vigilant management, with common adverse events including hypertension, fatigue, proteinuria, and diarrhea.
  • Lenvatinib often outperforms or matches the efficacy of other standard treatments across various cancer indications in both first and second-line settings. However, its advantage comes at the cost of increased toxicity, highlighting the need for a balanced approach to its use.
  • In conclusion, lenvatinib, as monotherapy and in combination with other agents like pembrolizumab/everolimus, offers significant advantages in treating various cancers. Its efficiency, particularly improving PFS and ORR, positions it as a potent therapeutic option against a range of malignancies, but the treatment's toxic side effects warrant careful patient management, emphasizing personalized treatment strategies to optimize outcomes while minimizing risks.

Product Monograph / Prescribing Information

Document TitleYearSource
Lenvima (lenvatinib) Prescribing Information.2024Eisai Inc., Woodcliff Lake, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Tyrosine kinase inhibitors for radioiodine refractory differentiated thyroid cancer: a systematic review and meta-analysis.2024Clinical Endocrinology
Immune-related adverse events associated with first-line immune checkpoint inhibitors for metastatic renal cell carcinoma: a systematic review and network meta-analysis.2024International Immunopharmacology
Assessing patient risk, benefit, and outcomes in drug development: a decade of lenvatinib clinical trials: a systematic review.2024Targeted Oncology
Lenvatinib versus atezolizumab plus bevacizumab in the first-line treatment for unresectable hepatocellular carcinoma: a meta-analysis of real-world studies.2024Targeted Oncology
Tyrosine kinase inhibitors in patients with advanced anaplastic thyroid cancer: an effective analysis based on real-world retrospective studies.2024Frontiers in Endocrinology
Comparative efficacy and safety of multimodality treatment for advanced hepatocellular carcinoma with portal vein tumor thrombus: patient-level network meta-analysis.2024Frontiers in Oncology
Efficacy and toxicity of immune checkpoint inhibitors combination therapy for advanced renal cell carcinoma: a systematic review and network meta-analysis.2024Frontiers in Immunology
Atezolizumab plus bevacizumab versus lenvatinib for hepatocellular carcinoma: a systematic review and meta-analysis.2024Journal of Clinical Pharmacology
Network meta-analysis of second line and beyond treatment options in metastatic clear cell renal cell carcinoma.2024Urologic Oncology
Updated systematic review and network meta-analysis of first-line treatments for metastatic renal cell carcinoma with extended follow-up data.2024Cancer Immunology, Immunotherapy
Transarterial chemoembolization combined with lenvatinib for hepatocellular carcinoma: a systematic review and meta-analysis of randomized controlled trials.2024Oncology
Efficacy and safety comparison between Lenvatinib and Sorafenib in hepatocellular carcinoma treatment: a systematic review and meta-analysis of real-world study.2024European Journal of Gastroenterology & Hepatology
Efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2023Journal of Cancer Research and Clinical Oncology
Efficacy and safety of transarterial chemoembolization plus lenvatinib with or without programmed death-1 inhibitors in the treatment of unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2023Journal of Cancer Research and Clinical Oncology
Immunotherapy and targeted therapies efficacy in thymic epithelial tumors: a systematic review.2023Biomedicines
Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis.2023Frontiers in Pharmacology
Atezolizumab plus bevacizumab versus lenvatinib as first-line therapy for advanced hepatocellular carcinoma: a systematic review and meta-analysis.2023Clinical and Experimental Hepatology
Efficacy and safety of transarterial chemoembolization plus lenvatinib in the treatment of advanced hepatocellular carcinoma: a meta-analysis.2023Medicine
First-line systemic treatment for hepatocellular carcinoma: a systematic review and network meta-analysis.2023Heliyon
Efficacy of transarterial therapy combined with first-line tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: a network meta-analysis.2023World Journal of Surgical Oncology
Pembrolizumab plus lenvatinib in advanced endometrial cancer: case report and systematic review of lung toxicity.2023Frontiers in Oncology
Lenvatinib in the treatment of unresectable hepatocellular carcinoma: a systematic review of economic evaluations.2023European Journal of Clinical Pharmacology
Metabolic adverse events of multitarget kinase inhibitors: a systematic review.2023Endocrine
Corrigendum: Transarterial chemoembolization combined with lenvatinib versus transarterial chemoembolization combined with sorafenib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2023Frontiers in Oncology
Safety and efficacy of TACE + lenvatinib in treating advanced hepatocellular carcinoma: a systematic review and meta-analysis.2023Journal of Gastrointestinal and Liver Diseases
Clinical efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib in the treatment of advanced hepatocellular carcinoma: a systematic review and meta-analysis.2023Medicine
First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis.2023Cancer Immunology, Immunotherapy
Comparative efficacy and safety of molecular targeted agents combined with transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma: a network meta-analysis.2023Frontiers in Oncology
First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.2023Cochrane Database of Systematic Reviews
Systemic therapy with or without locoregional therapy for advanced hepatocellular carcinoma: a systematic review and network meta-analysis.2023Critical Reviews in Oncology/Hematology
The treatment of transarterial chemoembolization/hepatic arterial infusion chemotherapy combined with lenvatinib and PD-1 inhibitor is effective against hepatocellular carcinoma with portal vein tumor thrombus: a systematic review.2023Frontiers in Oncology
A meta-analysis of the efficacy and toxicity of tyrosine kinase inhibitors in treating patients with different types of thyroid cancer: how to choose drugs appropriately?2023Current Opinion in Oncology
Efficacy of transarterial chemoembolization combined with tyrosine kinase inhibitors for hepatocellular carcinoma patients with portal vein tumor thrombus: a systematic review and meta-analysis.2023Current Oncology
Efficacy and safety of transarterial chemoembolization plus lenvatinib with or without programmed death-1 inhibitors in the treatment of unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2023Journal of Cancer Research
Efficacy and safety of atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2023Journal of Cancer
Everolimus and temsirolimus are not the same second-line in metastatic renal cell carcinoma: a systematic review and meta-analysis.2023Cost Effectiveness and Resource Allocation
Optimizing targeted drug selection in combination therapy for patients with advanced or metastatic renal cell carcinoma: a systematic review and network meta-analysis of safety.2023Cancer Medicine
Comparing efficacy and safety of first-line treatment of metastatic renal cell carcinoma: a Bayesian network meta-regression analysis.2023Frontiers in Oncology
Comparison of the effects of lenvatinib and sorafenib on survival in patients with advanced hepatocellular carcinoma: a systematic review and meta-analysis.2023Clinics and Research in Hepatology and Gastroenterology
Impact of post-progression survival on outcomes of lenvatinib treatment for unresectable hepatocellular carcinoma: a systematic review and retrospective cohort study.2022Anticancer Research
IO-IO vs IO-TKI efficacy in metastatic kidney cancer patients: a structured systematic review over time.2022Seminars in Oncology
Comparative efficacy of novel combination strategies for unresectable hepatocellular carcinoma: a network meta-analysis of phase III trials.2022European Journal of Cancer
Ranking of transarterial and targeted therapies for advanced hepatocellular carcinoma in the era of immuno-oncology: a network meta-analysis of randomized sorafenib-controlled trials.2022Hepatology Communications
Systemic therapies for metastatic renal cell carcinoma in the second-line setting: a systematic review and network meta-analysis.2022Medicine
Efficacy and safety of targeted therapeutics for patients with radioiodine-refractory differentiated thyroid cancer: Systematic review and network meta-analysis.2022Frontiers in Pharmacology
The effect of immune checkpoint inhibitor combination therapies in metastatic renal cell carcinoma patients with and without previous cytoreductive nephrectomy: a systematic review and meta-analysis.2022International Immunopharmacology
Efficacy and safety of lenvatinib in anaplastic thyroid carcinoma: a meta-analysis.2022Frontiers in Endocrinology
Evolving landscape of first-line combination therapy in advanced renal cancer: a systematic review.2022Therapeutic Advances in Medical Oncology
New first-line immunotherapy-based combinations for metastatic renal cell carcinoma: a systematic review and network meta-analysis.2022Cancer Treatment Reviews
Clinical outcomes and adverse events after first-line treatment in metastatic renal cell carcinoma: a systematic review and network meta-analysis.2022The Journal of Urology
Efficacy and safety of first-line systemic therapy for metastatic renal cell carcinoma: a systematic review and network meta-analysis.2022European Urology Open Science
Dermatological adverse events associated with immune checkpoint inhibitor-based combinations of anticancer therapies: a systematic review.2022Immunotherapy
First- and second-line treatments for patients with advanced hepatocellular carcinoma in China: a systematic review.2022Current Oncology
Incidence and risk of hypertension with lenvatinib in the treatment of solid tumors: an updated systematic review and meta-analysis.2022The Journal of Clinical Hypertension
Efficacy and safety of lenvatinib versus sorafenib in first-line treatment of advanced hepatocellular carcinoma: a meta-analysis.2022Frontiers in Oncology
Lenvatinib as first-line treatment for unresectable hepatocellular carcinoma: a systematic review and meta-analysis.2022Cancers
Clinical outcomes and adverse events after first-line treatment in metastatic renal cell carcinoma: a systematic review and network meta-analysis.2022The Journal of Urology
How immunotherapy modified the therapeutic scenario of endometrial cancer: a systematic review.2022Frontiers in Oncology
First-line systemic treatment strategies for unresectable hepatocellular carcinoma: a systematic review and network meta-analysis of randomized clinical trials.2021Frontiers in Oncology
First-line immunotherapy-based combinations for metastatic renal cell carcinoma: a systematic review and network meta-analysis.2021European Urology Oncology
Differences in oncological and toxicity outcomes between programmed cell death-1 and programmed cell death ligand-1 inhibitors in metastatic renal cell carcinoma: a systematic review and meta-analysis.2021Cancer Treatment Reviews
Evidence-based management of hepatocellular carcinoma: systematic review and meta-analysis of randomized controlled trials (2002-2020).2021Gastroenterology
Clinical efficacy of lenvatinib for the treatment of radioiodine-refractory thyroid carcinoma: a systematic review and meta-analysis of clinical trials.2021Clinical Endocrinology
Non-surgical management of advanced hepatocellular carcinoma: a systematic review by Cancer Care Ontario.2021Canadian Liver Journal
Comparative evaluation of cardiovascular risks among nine FDA-approved VEGFR-TKIs in patients with solid tumors: a Bayesian network analysis of randomized controlled trials.2021Journal of Cancer Research and Clinical Oncology
Adverse events of systemic immune-based combination therapies in the first-line treatment of patients with metastatic renal cell carcinoma: systematic review and network meta-analysis.2021Current Opinion in Urology
Selection of first-line systemic therapies for advanced hepatocellular carcinoma: a network meta-analysis of randomized controlled trials.2021World Journal of Gastroenterology
The efficacy and safety of lenvatinib in the treatment of solid tumors: an up-to-date meta-analysis.2021Future Oncology
Safety and efficacy of pembrolizumab plus lenvatinib versus pembrolizumab and lenvatinib monotherapies in cancers: a systematic review.2021International Immunopharmacology
A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma.2021Journal of Clinical Pharmacy and Therapeutics
Lenvatinib versus sorafenib as first-line therapy of advanced hepatocellular carcinoma: a systematic review and meta-analysis.2021American Journal of Translational Research
Efficacy of first-line systemic chemotherapy and multikinase inhibitors in advanced hepatocellular carcinoma: a systematic review and network meta-analysis.2021Frontiers in Oncology
Comparison of efficacy of systemic therapies in advanced hepatocellular carcinoma: updated systematic review and frequentist network meta-analysis of randomized controlled trials.2021Journal of Hepatocellular Cancer
Bleeding with vascular endothelial growth factor tyrosine kinase inhibitor: a network meta-analysis.2021Liver Cancer
Bleeding with vascular endothelial growth factor tyrosine kinase inhibitor: a network meta-analysis.2021Critical Reviews in Oncology/Hematology
Clinical efficacy of lenvatinib for the treatment of radioiodine-refractory thyroid carcinoma: a systematic review and meta-analysis of clinical trials.2021Clinical Endocrinology
Optimizing survival and the changing landscape of targeted therapy for intermediate and advanced hepatocellular carcinoma: a systematic review.2021Journal of the National Cancer Institute
Selection of first-line systemic therapies for advanced hepatocellular carcinoma: a network meta-analysis of randomized controlled trials.2021World Journal of Gastroenterology
A systematic literature review and network meta-analysis of first-line treatments for unresectable hepatocellular carcinoma based on data from randomized controlled trials.2021Expert Review of Anticancer Therapy
Comparative efficacy and safety of tyrosine kinase inhibitors for thyroid cancer: a systematic review and meta-analysis.2020Endocrine Journal
Targeted and immune therapies among patients with metastatic renal carcinoma undergoing hemodialysis: a systematic review.2020Seminars in Oncology
First-line targeted therapies of advanced hepatocellular carcinoma: a Bayesian network analysis of randomized controlled trials.2020PLoS One
Anti-tumor activity and safety of multikinase inhibitors in advanced and/or metastatic thyroid cancer: a systematic review and network meta-analysis of randomized controlled trials.2020Hormone and Metabolic Research
Systemic therapy and sequencing options in advanced hepatocellular carcinoma: a systematic review and network meta-analysis.2020JAMA Oncology
Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation.2020Health Technology Assessment
Relative efficacy of systemic treatments for patients with advanced hepatocellular carcinoma according to viral status: a systematic review and network meta-analysis.2019Target Oncology
A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine.2019BMC Cancer
Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis.2019BMJ Open
Treatment-related adverse effects with TKIs in patients with advanced or radioiodine refractory differentiated thyroid carcinoma: a systematic review and meta-analysis2019Cancer Management and Research
Second-line treatments of advanced hepatocellular carcinoma: systematic review and network meta-analysis of randomized controlled trials2019Journal of Clinical Gastroenterology

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