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FDA approves kinase inhibitor for advanced RCC


The FDA has approved the oral kinase inhibitor axitinib (Inlyta) for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy.

The approval is based on data from the phase III AXIS trial, which demonstrated that axitinib significantly extended progression-free survival ([PFS] HR=0.67, 0.54-0.81, p

Axitinib is designed to selectively inhibit vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.

"Through studying this drug, we have learned that a VEGFR-targeted therapy can be effective following prior treatment options, including another VEGFR-targeted agent," said Brian I. Rini, MD, of Cleveland Clinic’s Taussig Cancer Institute. "This is important in helping physicians understand where these medications fit in the treatment armamentarium."

The most common (≥20%) adverse events occurring in patients receiving axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome, weight decreased, vomiting, asthenia, and constipation. The most common (≥10%) grade 3/4 adverse events were hypertension, diarrhea, and fatigue.

Axitinib is also being investigated in a clinical trial in patients with treatment-naïve as well as previously treated advanced RCC. In addition, under a collaborative development agreement between Pfizer and SFJ Pharma Ltd. II, SFJ will conduct a phase III clinical trial in Asia studying the drug for adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy.

Dr. Rini is a consultant/adviser for Pfizer, Inc. and has received research funding from the company.

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