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The FDA has approved the use of Inlyta (axitinib) to treat patients with advanced kidney cancer, renal cell carcinoma, who do not respond to other treatment options. The Pfizer-marketed drug is a pill, taken twice daily.


This marks the seventh drug to be approved for metastatic or advanced renal cell cancer since 2005, including pazopanib (2009), bevacizumab (2009), everolimus (2009), temsirolimus (2007), sunitinib (2006), and sorafenib (2005).


"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," said Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research.


The drug works by blocking the kinases that allow the tumor to grow and the cancer to progress. A single, randomized, open-label, multicenter clinical study of 723 renal cell carcinoma patients found the drug effective and safe, and also found a median progression-free survival time of 6.7 months compared with 4.7 months with a standard treatment (sorafenib), according to the FDA statement.