Axitinib (Inlyta)

==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.Axitinib (Inlyta) package insert Axitinib (Inlyta) package insert (locally hosted backup)Inlyta manufacturer's websiteMatthew 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.
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 or the prescribing information.
==Diseases for which it is established (work in progress)==
*Renal cell carcinoma
==Diseases for which it is used==
*Hepatocellular carcinoma
*Thyroid cancer
**Differentiated thyroid cancer
**Medullary thyroid cancer
==Patient drug information==
*Inlyta Side Effect Tips & Videos (Pfizer)Inlyta Side Effect Tips & Videos (Pfizer)
*Axitinib (Inlyta) package insert
*Axitinib (Inlyta) patient drug information (Chemocare)Axitinib (Inlyta) patient drug information (Chemocare)
*Axitinib (Inlyta) patient drug information (UpToDate)Axitinib (Inlyta) patient drug information (UpToDate)
==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==
*2012-06-29: Initial approval for the treatment of unresectable or metastatic renal cell carcinoma.
==Also known as==
*Code names: AG-013736
*Brand name: Axilieva, Axinix, Axishil, Axpero, Axzyb, Bexinib, Inlybest, Inlyta, Jastinib, Kytib, Luciax, Oxishil, Raxitinib, Tajaxit, Tiziax
==References==
Category:Drugs
Category:Oral medications
Category:KIT inhibitors
Category:PDGFR inhibitors
Category:VEGFR inhibitors
Category:Hepatocellular carcinoma medications
Category:Clear cell renal cell carcinoma medications
Category:Thyroid cancer medications
Category:Thyroid cancer, differentiated medications
Category:Thyroid cancer, medullary medications
Category:EMA approved in 2012
Category:FDA approved in 2012
Category:Health Canada approved in 2012
Category:PMDA approved in 2012