CometriqTreatment for Thyroid Cancer
Update: Cometriq (cabozantinib) Now FDA Approved - November 29, 2012
Exelixis Provides Update on ODAC Panel for Cabozantinib
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 29, 2012 - Exelixis, Inc. 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.
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.
Contact: Exelixis, Inc.
Charles Butler, 650-837-7277
Vice President, Investor Relations and Corporate Communications
Posted: August 2012
- FDA Approves Cometriq (cabozantinib) to Treat Rare Type of Thyroid Cancer - November 29, 2012
- FDA Grants Priority Review for Cabozantinib in Medullary Thyroid Cancer - July 30, 2012
- Exelixis Completes Submission of New Drug Application for Cabozantinib for the Treatment of Medullary Thyroid Cancer - May 30, 2012