Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma


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The FDA has approved the kinase inhibitor axitinib (Inlyta) 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 that enrolled 723 patients: 361 were assigned to receive axitinib at 5 mg orally twice daily, and 362 patients were assigned to receive sorafenib (Nexavar) at 400 mg orally twice daily. All patients had received one prior systemic therapy that contained one of the following treatments: sunitinib (Sutent), temsirolimus (Torisel), bevacizumab (Avastin), or cytokine(s) (interleukin-2 [Proleukin] or interferon-alfa). The trial excluded patients who had uncontrolled hypertension.

The trial demonstrated a statistically significant improvement in progression-free survival in patients receiving the kinase inhibitor axitinib compared to patients receiving sorafenib (HR = 0.67; 95% CI = 0.54–0.81; < .0001, log-rank test). The median progression-free survival of patients receiving axitinib was 6.7 months (95% CI = 6.3–8.6) compared to 4.7 months (95% CI = 4.6–5.6) for the sorafenib arm. This improvement in progression-free survival 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 syndrome, weight decrease, vomiting, asthenia, and constipation. ■



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