Exelixis Provides Update On ODAC Panel For Cabozantinib
Exelixis, Inc. (NASDAQ: EXEL) today was notified by the Food and Drug Administration (the “FDA”) that the Company’s new drug application (“NDA”) 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 FDA’s Oncologic Drugs Advisory Committee (“ODAC”). 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 November 29, 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.
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