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FDA approves Inlyta to treat advanced kidney cancer

Saturday, January 28, 2012 08:27 AM

The FDA has approved Pfizer’s Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Inlyta treats renal cell carcinoma—a kidney cancer that starts in the lining of very small tubes in the kidney—by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. Inlyta is a pill patients take twice a day.

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival—the time a patient lived without the cancer progressing.

Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

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