FDA Approved Drugs » 2012
Medical Areas: Nephrology | Oncology | Family Medicine | Hepatology (Liver, Pancreatic, Gall Bladder)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 2012
Treatment Area: advanced renal cell carcinoma
Inlyta (axitinib) is a kinase inhibitor. It has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.
Inlyta was specifically approved for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.
Inlyta is supplied as a tablet for oral administration. The recommended starting dose of Inlyta is 5 mg twice daily. Doses should be administered approximately 12 hours apart with or without food. The tablet should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. If the initial dose is well tolerated after two weeks, the Inlyta dose may be increased. When a dose increase from 5 mg twice daily is recommended, the Inlyta dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria. If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily.
FDA ApprovalThe FDA approval of Inlyta was based on a randomized, open-label, multicenter phase III study. A total of 723 subjects with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy were randomized to receive Inlyta or sorafenib (Nexavar- current standard of care). The primary endpoint was progression free survival (PFS). There was a statistically significant advantage for Inlyta over sorafenib for the endpoint of PFS. The median PFS in the Inlyta treatment arm was 6.7 months versus 4.7 months in the sorafenib arm (p<0.0001).
Adverse events associated with the use of Inlyta may include, but are not limited to, the following:
Inlyta (axitinib) is a kinase inhibitor. It has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.
Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011 Dec 3;378(9807):1931-9
Rini BI, Wilding G, Hudes G, Stadler WM, Kim S, Tarazi J, Rosbrook B, Trask PC, Wood L, Dutcher JP Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 2009 Sep 20;27(27):4462-8
For additional information regarding Inlyta or renal cell carcinoma, please visit the Pfizer products web page.