Difference between revisions of "Axitinib (Inlyta)"

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==General information==
 
==General information==
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Class/mechanism: Tyrosine kinase inhibitor of vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3, which interferes with tumor angiogenesis, growth, and cancer progression, at picomolar concentrations. Inhibits PDGFRA, PDGFRB and c-kit at nanomolar concentrations.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Axitinib (Inlyta) package insert]</ref><ref>[[Media:Axitinib.pdf | Axitinib (Inlyta) package insert (locally hosted backup)]]</ref><ref>[http://www.inlyta.com/ Inlyta manufacturer's website]</ref><ref>Matthew Stenger. [http://www.ascopost.com/articles/march-15-2012/what-you-need-to-know-about-axitinib/ What You Need to Know About Axitinib, New Agent for Treating Advanced Renal Cell Carcinoma]. ASCO Post, March 15, 2012, Volume 3, Issue 5.</ref>
+
Class/mechanism: Tyrosine kinase inhibitor of vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3, which interferes with tumor angiogenesis, growth, and cancer progression, at picomolar concentrations. Inhibits PDGFRA, PDGFRB and c-kit at nanomolar concentrations.<ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Axitinib (Inlyta) package insert]</ref><ref>[[:File:Axitinib.pdf | Axitinib (Inlyta) package insert (locally hosted backup)]]</ref><ref>[http://www.inlyta.com/ Inlyta manufacturer's website]</ref><ref>Matthew Stenger. [http://www.ascopost.com/articles/march-15-2012/what-you-need-to-know-about-axitinib/ What You Need to Know About Axitinib, New Agent for Treating Advanced Renal Cell Carcinoma]. ASCO Post, March 15, 2012, Volume 3, Issue 5.</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
  
 
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
 
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
 +
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Renal cell carcinoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Hepatocellular carcinoma]]
 
*[[Hepatocellular carcinoma]]
−
*[[Renal cell carcinoma]]
 
 
*[[Thyroid cancer]]
 
*[[Thyroid cancer]]
 +
**[[Differentiated thyroid cancer]]
 +
**[[Medullary thyroid cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
 
*[http://www.inlyta.com/side-effect-tips Inlyta Side Effect Tips & Videos (Pfizer)]<ref>[http://www.inlyta.com/side-effect-tips Inlyta Side Effect Tips & Videos (Pfizer)]</ref>
 
*[http://www.inlyta.com/side-effect-tips Inlyta Side Effect Tips & Videos (Pfizer)]<ref>[http://www.inlyta.com/side-effect-tips Inlyta Side Effect Tips & Videos (Pfizer)]</ref>
 
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Axitinib (Inlyta) package insert]<ref name="insert"></ref>
 
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Axitinib (Inlyta) package insert]<ref name="insert"></ref>
−
*[http://chemocare.com/chemotherapy/drug-info/axitinib.aspx Axitinib (Inlyta) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/axitinib.aspx Axitinib (Inlyta) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/axitinib.aspx Axitinib (Inlyta) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/axitinib.aspx Axitinib (Inlyta) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/axitinib-patient-drug-information Axitinib (Inlyta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/axitinib-patient-drug-information Axitinib (Inlyta) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/axitinib-patient-drug-information Axitinib (Inlyta) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/axitinib-patient-drug-information Axitinib (Inlyta) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*1/27/2012: Initial approval for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]] after failure of one prior systemic therapy.
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*2012-01-27: Initial approval for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]] after failure of one prior systemic therapy. ''(Based on AXIS)''
−
*5/14/2019: Approved in combination with [[Avelumab (Bavencio)|avelumab]] for first-line treatment of patients with advanced [[Renal cell carcinoma|renal cell carcinoma (RCC)]]. ''(Approval extended to first-line setting, in combination)''
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*2019-05-14: Approved in combination with [[Avelumab (Bavencio)|avelumab]] for first-line treatment of patients with advanced [[Renal cell carcinoma|renal cell carcinoma (RCC)]]. ''(Approval extended to first-line setting, in combination; based on JAVELIN Renal 101)''
 +
*2020-06-04: Approved in combination with pembrolizumab, for the first-line treatment of patients with advanced [[Renal cell carcinoma|RCC]]. ''(Based on KEYNOTE-426)''
  
 +
==History of changes in EMA indication==
 +
*2012-09-03: Initial marketing authorization as Inlyta. Inlyta is indicated for the treatment of adult patients with advanced [[Renal cell carcinoma |renal cell carcinoma (RCC)]] after failure of prior treatment with sunitinib or a cytokine. ''(Based on AXIS)''
 +
 +
==History of changes in Health Canada indication==
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*2012-07-12: Initial notice of compliance
 +
*Uncertain date: Indicated for the treatment of patients with metastatic [[Clear cell renal cell carcinoma|renal cell carcinoma (RCC) of clear cell histology]] after failure of prior systemic therapy with either a cytokine or the VEGFR-TKI, sunitinib.
 +
*Uncertain date: in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or metastatic [[Renal cell carcinoma|renal cell carcinoma (RCC)]] with no prior systemic therapy for metastatic RCC.
 +
==History of changes in PMDA indication==
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*2012-06-29: Initial approval for the treatment of unresectable or metastatic [[renal cell carcinoma]].
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' AG013736, AG-013736
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*'''Code names:''' AG-013736
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*'''Brand name:''' Inlyta
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*'''Brand name:''' Axishil, Axpero, Inlybest, Inlyta, Luciax
  
 
==References==
 
==References==
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[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
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[[Category:KIT inhibitors]]
 
[[Category:KIT inhibitors]]
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[[Category:Hepatocellular carcinoma medications]]
 
[[Category:Hepatocellular carcinoma medications]]
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[[Category:Renal_cell_carcinoma medications]]
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[[Category:Clear cell renal cell carcinoma medications]]
 
[[Category:Thyroid cancer medications]]
 
[[Category:Thyroid cancer medications]]
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[[Category:Thyroid cancer, differentiated medications]]
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[[Category:Thyroid cancer, medullary medications]]
  
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[[Category:EMA approved in 2012]]
 
[[Category:FDA approved in 2012]]
 
[[Category:FDA approved in 2012]]
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[[Category:Health Canada approved in 2012]]
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[[Category:PMDA approved in 2012]]

Revision as of 01:11, 7 November 2023

General information

Class/mechanism: Tyrosine kinase inhibitor of vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3, which interferes with tumor angiogenesis, growth, and cancer progression, at picomolar concentrations. Inhibits PDGFRA, PDGFRB and c-kit at nanomolar concentrations.[1][2][3][4]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2012-01-27: Initial approval for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. (Based on AXIS)
  • 2019-05-14: Approved in combination with avelumab for first-line treatment of patients with advanced renal cell carcinoma (RCC). (Approval extended to first-line setting, in combination; based on JAVELIN Renal 101)
  • 2020-06-04: Approved in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. (Based on KEYNOTE-426)

History of changes in EMA indication

  • 2012-09-03: Initial marketing authorization as Inlyta. Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. (Based on AXIS)

History of changes in Health Canada indication

  • 2012-07-12: Initial notice of compliance
  • Uncertain date: Indicated for the treatment of patients with metastatic renal cell carcinoma (RCC) of clear cell histology after failure of prior systemic therapy with either a cytokine or the VEGFR-TKI, sunitinib.
  • Uncertain date: in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) with no prior systemic therapy for metastatic RCC.

History of changes in PMDA indication

Also known as

  • Code names: AG-013736
  • Brand name: Axishil, Axpero, Inlybest, Inlyta, Luciax

References

  1. ↑ 1.0 1.1 1.2 Axitinib (Inlyta) package insert
  2. ↑ Axitinib (Inlyta) package insert (locally hosted backup)
  3. ↑ Inlyta manufacturer's website
  4. ↑ Matthew Stenger. What You Need to Know About Axitinib, New Agent for Treating Advanced Renal Cell Carcinoma. ASCO Post, March 15, 2012, Volume 3, Issue 5.
  5. ↑ Inlyta Side Effect Tips & Videos (Pfizer)
  6. ↑ Axitinib (Inlyta) patient drug information (Chemocare)
  7. ↑ Axitinib (Inlyta) patient drug information (UpToDate)
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