Difference between revisions of "Axitinib (Inlyta)"

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*2012-09-03: Initial marketing authorization as Inlyta.
 
*2012-09-03: Initial marketing authorization as Inlyta.
 
*Uncertain date: 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.
 
*Uncertain date: 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.
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==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
 
*'''Code names:''' AG013736, AG-013736
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[[Category:EMA approved in 2012]]
 
[[Category:EMA approved in 2012]]
 
[[Category:FDA approved in 2012]]
 
[[Category:FDA approved in 2012]]
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[[Category:PMDA approved in 2012]]

Revision as of 00:22, 10 June 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.
  • Uncertain date: 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.

History of changes in PMDA indication

Also known as

  • Code names: AG013736, 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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