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Pfizer Says FDA Panel Backs Benefit/Risk Profile Of Axitinib In Kidney Cancer

Pfizer Inc. (PFE) said Friday a panel of the US Food and Drug Administration unanimously supported the benefit/risk data of its kidney cancer drug axitinib in patients with advanced renal cell carcinoma or RCC who failed an earlier treatment.

The FDA's Oncologic Drugs Advisory Committee or ODAC voted 13 to 0, saying that Pfizer's investigational agent axitinib offered more benefits than risks in previously treated advanced RCC patients.

The FDA usually considers the ODAC panel's recommendation when deciding on Pfizer's New Drug Application for axitinib, though it is not bound to do so. The ODAC panel reviewed data on axitinib, including results from the Phase 3 AXIS trial of patients whose disease had progressed following treatment with one systemic therapy.

Renal cell carcinoma is a kidney cancer that originates in the lining of the proximal convoluted tubule, or small tubes in the kidney that filter the blood and eliminates wastes. About 58,000 new cases of RCC are diagnosed in the US annually, with nearly 20 to 30 percent reaching an advanced stage.

Pfizer's axitinib is an oral therapy designed to selectively inhibit certain vascular endothelial growth factor receptors that can influence tumor growth. If approved by the FDA, axitinib might compete with with tivozanib, which is being studied by Aveo Pharmaceuticals Inc. (AVEO). Another drug is Bayer AG's Nexavar, an approved medication that had sales of $177 million in Bayer's third quarter.

PFE is trading at $20.46, up $0.23 or 1.14%, on a volume of over 21 million shares on the NYSE.

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