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FDA approves Pfizer's Inlyta for advanced kidney cancer


SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

"This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer and offers patients multiple treatment options."

The other six drugs approved for advanced or metastatic kidney cancer since 2005 are Nexavar (sorafenib), made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals; Pfizer's Sutent (sunitinib) and Torisel (temsirolimus); Novartis' Afinitor (everolimus); Genentech's Avastin (bevacizumab); and GlaxoSmithKline's Votrient (pazopanib).

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