Pfizer Inc. (PFE) said Friday the U.S. Food and Drug Administration approved its kidney cancer drug Inlyta to treat patients with advanced renal cell carcinoma who failed a standard treatment.
The approval follows an unanimous recommendation by a FDA panel last month that Inlyta (Axitinib) had a favorable benefit-risk profile.
Renal cell carcinoma, or RCC, is a kidney cancer that starts in the lining of very small tubes in the kidney that filter the blood and eliminates wastes. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth. Inlyta is to be taken twice a day by patients.
According to the American Cancer Society, about 13,000 individuals die of advanced RCC in the U.S. each year. Nearly 60,000 new cases are diagnosed in the U.S. annually.
According to the FDA, Inlyta is the seventh drug approved to treat advanced RCC since 2005. These include Pfizer's Sutent, Roche Holding AG's (RHHBY, ROG.VX) Avastin, and Bayer AG's Nexavar that had sales of $177 million in its third quarter.
Inlyta also might compete with tivozanib being studied by Aveo Pharmaceuticals Inc. (AVEO), which recently revealed positive latestage results for the drug.
The FDA approval for Inlyta was based on a randomized, open-label study of 723 patients whose disease had progressed on or after treatment with a prior systemic therapy. Study results showed a median progression-free survival of 6.7 months for Inlyta, compared to 4.7 months with standard care sorafenib.
Inlyta is also being evaluated in a randomized trial in patients with treatment-naïve as well as previously treated advanced RCC, and in a randomized Phase 2 clinical trial for the treatment of hepatocellular carcinoma.
The Inlyta approval comes as Pfizer, like other drug makers, grapples with generic competition. Last December, Pfizer lost rights for cholesterol-lowering Lipitor - the world's largest selling drug that generated sales of $7.89 billion in the U.S. through September 2011.
PFE is trading at $21.50, down $0.13 or 0.62%, on the NYSE.
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