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FDA Approval for Axitinib

Brand name: Inlyta®

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On January 27, 2012, the Food and Drug Administration (FDA) approved axitinib tablets (Inlyta®, made by Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after the 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 the 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, or withdrawal of consent. 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 with patients receiving sorafenib (HR=0.67; 95 percent CI: 0.54, 0.81; p< 0.0001, log-rank test). The median PFS of patients receiving axitinib was 6.7 months (95 percent CI: 6.3, 8.6) compared with a median PFS of 4.7 months (95 percent CI: 4.6, 5.6) for patients receiving sorafenib.  This improvement in PFS was greater in the cytokine-pretreated subgroup in comparison with the sunitinib-pretreated subgroup.

The most common (at least 20 percent) adverse reactions in patients treated with axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, decrease in weight, vomiting, asthenia, and constipation. Other severe adverse reactions reported in patients treated with axitinib 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.

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

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  • Updated: July 1, 2013