The Lynx Group

FDA Approves Axitinib for Advanced Renal-Cell Carcinoma

February 2012, Vol 3, No 1

The FDA approved the newest oral kinase inhibitor axitinib (Inlyta; Pfizer) for the treatment of patients with advanced renal-cell carcinoma that has failed to respond to previous therapy. Axitinib selectively inhibits vascular growth factor receptors 1, 2, and 3 that promote tumor growth, vascular angiogenesis, and tumor progression.

The approval was based on the phase 3 AXIS trial, an open-label study of 723 patients with advanced renal-cell carcinoma that had progressed after 1 previous round of systemic therapy with sunitinib, bevacizumab, temsirolimus, or a cytokine. Patients were randomized to receive axitinib 5 mg twice daily or to sorafenib 400 mg twice daily. 

The primary end point was progression-free survival (PFS). Treat­ment continued until disease progression, unacceptable toxicity, or withdrawal. Axitinib resulted in a 6.7-month PFS compared with 4.7 month with sorafenib, representing a 43% im­prove­ment in median PFS (P <.001). The objective response rate was 19.4% in the patients receiving axitinib compared with 9.4% in those receiving sorafenib.

The most frequent adverse events (≥20%) with axitinib were diarrhea, hypertension, fatigue, decreased ap­petite, nausea, dysphonia, palmar-plantar erythrodysesthesia syndrome, weight loss, vomiting, asthenia, and constipation.

The recommended dose is 5 mg twice daily, administered approxi­­mate­ly 12 hours apart. (January 27, 2012)

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