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On January 27, 2012, the U. S. Food and Drug Administration approved axitinib tablets (Inlyta, Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

The approval is based on an international, randomized, open-label trial in patients with advanced renal cell carcinoma after failure of one prior systemic regimen. The primary efficacy endpoint was progression-free survival (PFS).

The trial enrolled 723 patients: 361 patients were assigned to receive axitinib 5 mg orally twice daily, and 362 patients were assigned to receive sorafenib 400 mg orally twice daily. Treatment continued until disease progression, unacceptable toxicity, and/or consent withdrawal. All enrolled patients had an ECOG performance status of 0 or 1 and all patients had received one prior systemic therapy that contained one of the following treatments: sunitinib, temsirolimus, bevacizumab or cytokine(s). The trial excluded patients who had uncontrolled hypertension.

The PFS analysis demonstrated a statistically significant improvement in PFS in patients receiving axitinib compared to patients receiving sorafenib (HR=0.67; 95% CI: 0.54, 0.81; p< 0.0001, log-rank test). The median PFS of patients receiving axitinib was 6.7 months (95% CI: 6.3, 8.6) compared to a median PFS of 4.7 months (95% CI: 4.6, 5.6) for patients receiving sorafenib. This improvement in PFS was greater in the cytokine-pretreated subgroup compared to the sunitinib-pretreated subgroup.

The most common (≥20%) adverse reactions in patients treated with axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Other severe adverse reactions reported in axitinib-treated patients included hypertensive crisis, arterial and venous thrombotic events, hemorrhage, gastrointestinal perforation and fistula formation, and reversible posterior leukoencephalopathy syndrome.

The recommended dose schedule of axitinib is 5 mg orally twice daily, administered approximately 12 hours apart with or without a meal.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf 1

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm 2, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).