Exelixis, Inc. (NASDAQ: EXEL) today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ™ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union.
The MAA contains data from EXAM, the phase 3 pivotal study of COMETRIQ in progressive, metastatic MTC. This trial also served as the basis for Exelixis' New Drug Application with the U.S. Food and Drug Administration (FDA). The FDA approved COMETRIQ for the treatment of progressive, metastatic MTC on November 29, 2012.
COMETRIQ (cabozantinib) received orphan drug designation in the European Union from the Committee for Orphan Medicinal Products (COMP) for the treatment of MTC.