Axitinib

(Inlyta®)

Inlyta®

Drug updated on 4/15/2024

Dosage FormTablet (oral; 1 mg, 5 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
  • Indicated in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC.
  • Indicated as a single agent, for the treatment of advanced RCC after failure of one prior systemic therapy.

Latest News

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Summary
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  • Axitinib (Inlyta) is recommended for the initial treatment of advanced renal cell carcinoma (RCC), either in combination with avelumab or pembrolizumab, or as a monotherapy after the failure of one prior systemic therapy.
  • The analysis includes findings from 23 systematic reviews and meta-analyses focused on the applications of axitinib and its comparative safety and efficacy.
  • Compared to monotherapy with sunitinib, combinations that include axitinib have significantly improved progression-free survival (PFS) and overall survival rates, indicating a preference for combination therapy as a first-line approach in advanced RCC cases.
  • The combination of pembrolizumab and axitinib has shown to be superior at each measured time point in terms of overall survival and demonstrates fewer adverse events compared to other combinations, such as lenvatinib plus everolimus, which present higher risks of grade ≥3 adverse events.
  • The efficacy and safety outcomes are influenced by patient subgroups defined by risk criteria, including categories of favorable, intermediate, and poor-risk diseases, as well as specific characteristics such as PD-L1 expression. For example, avelumab combined with axitinib might be more beneficial for patients with a favorable-risk disease diagnosis.
  • Improved outcomes have been observed in elderly patient populations when treated with regimens such as pembrolizumab plus lenvatinib or nivolumab plus cabozantinib, compared to traditional treatments like sunitinib.
  • The swift move towards ICI-TKI combination therapies, including those involving axitinib, reflects significant advancements across various patient populations and risk groups, surpassing older treatment methods previously used.
  • Addressing the complexity of Adverse Events (AEs) while customizing therapy emphasizes the crucial role of expertise and comprehensive assessment in the ever-changing landscape of RCC treatment.

Product Monograph / Prescribing Information

Document TitleYearSource
Inlyta (axitinib) Prescribing Information.2022Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and toxicity of immune checkpoint inhibitors combination therapy for advanced renal cell carcinoma: a systematic review and network meta-analysis.2024Frontiers in Immunology
Comparing efficacy and safety of first-line treatment of metastatic renal cell carcinoma: A Bayesian network meta-regression analysis.2023Frontiers in Oncology
First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. 2023The Cochrane Database of Systematic Reviews
Efficacy and safety of checkpoint inhibitors in clear cell renal cell carcinoma: a systematic review of clinical trials. 2023Hematology/Oncology and Stem Cell Therapy
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
A systematic review to summarize treatment patterns, guidelines, and characteristics of patients with renal cell carcinoma in the Asia-Pacific region.2023Expert Review of Anticancer Therapy
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
Second-line treatments for advanced hepatocellular carcinoma: a systematic review and Bayesian network meta analysis. 2022Clinical and Experimental Medicine
Efficacy and safety of first-line systemic therapy for metastatic renal cell carcinoma: a systematic review and network meta-analysis. 2022European Association of Urology
First-line therapy for elderly patients with advanced renal cell carcinoma in the immuno-oncology era: a network meta-analysis2022Cancer Immunology, Immuno therapy
Evolving landscape of first-line combination therapy in advanced renal cancer: a systematic review2022Therapeutic Advances in Medical Oncology
Systemic therapy for metastatic renal cell carcinoma in the first‑line setting: a systematic review and network meta‑analysis.2021Cancer Immunology, Immunotherapy
A living, interactive systematic review and network meta-analysis of first-line treatment of metastatic renal cell carcinoma. 2021European Association of Urology
Median time to progression with TKI-based therapy after failure of immuno-oncology therapy in metastatic kidney cancer: a systematic review and meta-analysis. 2021European Journal of Cancer
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
Targeted therapy for metastatic renal cell carcinoma. 2020Cochrane Database of Systematic Reviews
What is the optimum systemic treatment for advanced/metastatic renal cell carcinoma of favourable, intermediate and poor risk, respectively? A systematic review and network meta-analysis.2020BMJ Open
First-line treatments for advanced renal cell carcinoma with immune checkpoint inhibitors: systematic review, network meta-analysis and cost-effectiveness analysis.2020Therapeutic Advances in Medical Oncology
Comparative efficacy of first-line immune-based combination therapies in metastatic renal cell carcinoma: a systematic review and network meta-analysis.2020Cancers
The clinical significance of routine risk categorization in metastatic renal cell carcinoma and its impact on treatment decision-making: a systematic review.2020Future Oncology
First-line Treatment of Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis.2019European Urology Oncology
Role of immune checkpoint inhibitor-based therapies for metastatic renal cell carcinoma in the first-line setting: A Bayesian network analysis.2019EBioMedicine
Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis2019BMJ Open

Clinical Practice Guidelines