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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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 ​​​​​​The content of this website has been produced in line with the INLYTA® (axitinib​​​​​​​) Summary of Product Characteristics for Great Britain. 
​​​​​​​
Prescribing Information for INLYTA® (axitinib) click here.  Prescribing Information for 
SUTENT® (sunitinib malate) click hereAdverse event reporting information can be found at the bottom of the page.

Efficacy

Mode of Action

INLYTA® is an inhibitor of multiple receptor tyrosine kinases (TKIs), including vascular endothelial growth factor receptors (VEGFR) required for angiogenesis.1 Dysregulation of the VEGF pathway is frequently associated with RCC, due to loss of function of the von Hippel-Lindau gene2, making mRCC a highly vascular tumour, and underlying why the VEGF pathway continues to be a target in RCC.2

Short Half-Life


'Half-life' is an estimate of the time that it takes for the amount of medicine in the body (usually measured as blood concentration) to be reduced by half

The short half-life of INLYTA® ensures that it is cleared more quickly following dose interruptions/discontinuations3,4


​​​​​​The half-life of INLYTA® is shorter than many of the other therapies used in mRCC (see Table below for a selection)3,5-12

​​​​​​​
INLYTA®  2.5-6.1 hours
Sorafenib  ~ 25-48 hours
Lenvantinib  ~ 28 hours
Everolimus  ~ 30 hours
Cabozantinib  ~ 110 hours
Tivozanib 108-122.4 hours
Sunitinib  40-60 hours (Sunitinib) and 80-110 hours (active metabolite of Sunitinib)      
Pazopanib  30.9 hours
Nivolumab  25 days
​​​​​​​
A short half-life means that AEs have the potential to be resolved quickly after treatment interruption4
​​​​

Clinical Study Data

AXIS2
Study Design
 

A randomised, multicentre, Phase III trial in 723 patients with mRCC with disease progression on first-line therapy (sunitinib or cytokine), comparing the efficacy and safety of INLYTA® 5mg twice daily and sorafenib 400 mg twice daily. 

INLYTA® is the only VEGFR-TKI that delivered superior outcomes vs another TKI after first-line sunitinib or cytokine in Phase III, second-line settings2,3

In a phase III clinical trial, INLYTA® demonstrated superior efficacy over sorafenib as second-line therapy2,3

PFS (primary endpoint)
Median PFS (ITT population) with INLYTA® vs sorafenib3

Median PFS (ITT population) with INLYTA vs sorafenib

​Kaplan-Meler curve of progression-free survival assessed by blinded independent radiology review committee for the overal ITT population (adapted from INLYTA® Summary of Product Characteristics)2,3

ORR (secondary endpoint)
ORR with INLYTA® vs sorafenib3

​​​​​ORR with INLYTA vs sorafenib
​​​​
ORR in the overall ITT population assessed by blinded independent radiology review committee (adapted from INLYTA® Summary of Product Characteristics)2,3


Safety
Common treatment-emergent all-causality (non-laboratory) adverse events2
​​​​​​​INLYTA Adverse Events Table comparing INLYTA & Sorafenib​​​​​​​

Safety

  • INLYTA® Safety Information

Safety

  • INLYTA® Safety Information

Indication

  • INLYTA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (aRCC) after failure of prior treatment with sunitinib or a cytokine1

​​​​​​​RCC : Renal Cell Carcinoma, ​​​​​​​aRCC : advanced Renal Cell Carcinoma

References
​​​​​​​

1. Chow LQ and Eckhardt SG. J clin Oncol 2007;25:884-896.
2. Rini BI, et al. Lancet 2011;378(9807):1931-1939
3. INLYTA® Summary of Product Characteristics for Great Britain click here. INLYTA® Summary of Product Characteristics for Northern Ireland click here.
4. Schmidinger M, et al. Future Oncol 2018;14:861–875.
5. Sorafenib Summary of Product Characteristics. Bayer. Available at: https://www.medicines.org.uk/emc/product/226/smpc. Accessed: February 2022.
6. Lenvatinib Summary of Product Characteristics. Eisai. Available at: https://www.medicines.org.uk/emc/product/7881/smpc. Accessed: February 2022.
7. Everolimus Summary of Product Characteristics. Novartis. Available at: https://www.medicines.org.uk/emc/product/6658/smpc. Accessed: February 2022.
8. Cabozantinib Summary of Product Characteristics. Ipsen. Available at: https://www.medicines.org.uk/emc/product/4331/smpc. Accessed: February 2022.
9. Nivolumab Summary of Product Characteristics. BMS. Available at: https://www.medicines.org.uk/emc/product/6888. Accessed: February 2022.
10. Pazopanib Summary of Product Characteristics. Novartis. Available at: https://www.medicines.org.uk/emc/product/7861/smpc. Accessed: February 2022.
11. Sunitinib Summary of Product Characteristics. Pfizer. ​​​​​Available at: https://www.medicines.org.uk/emc/product/227/smpc. Accessed: February 2022.
12. Tivozanib Summary of Product Characteristics. EUSA. Available at: https://www.medicines.org.uk/emc/product/8995/smpc. Accessed: February 2022.
​​​​​​​​​​​​

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