Close

Pfizer (PFE) Gets Favorable Outcome for Axitinib from FDA Committee

December 7, 2011 11:43 AM EST
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational agent axitinib support a favorable benefit/risk profile for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of a first-line systemic therapy. The ODAC panel’s recommendation will be considered by the FDA when making its decision regarding Pfizer’s New Drug Application (NDA) for axitinib as a treatment for advanced RCC.

Approximately 58,000 new cases of RCC are diagnosed in the United States each year, and approximately 20 to 30 percent of these patients have advanced disease at the time of diagnosis. Around 13,000 individuals die of this tumor in the U.S. each year.


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA