Health & Fitness
Thu, August 30, 2012
SOUTH SAN FRANCISCO, Calif.--([ BUSINESS WIRE ])--Exelixis, Inc. (NASDAQ: EXEL) today was notified by the Food and Drug Administration (the aFDAa) that the Companyas new drug application (aNDAa) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer has been removed from the agenda for the November 8 and November 9, 2012 meeting of the FDAas Oncologic Drugs Advisory Committee (aODACa). As a result, the Company does not anticipate a discussion of the NDA by ODAC.The previously announced Prescription Drug User Fee Act (PDUFA) action date remains November29, 2012.
About Exelixis
Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on cabozantinib (XL184), its most advanced product candidate, in order to maximize the therapeutic and commercial potential of this compound. Exelixis believes cabozantinib has the potential to be a high-quality, broadly-active, differentiated pharmaceutical product that can make a meaningful difference in the lives of patients. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations. For more information, please visit the company's web site at [ http://www.exelixis.com ].