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Exelixis, Inc. (EXEL) Release: COMETRIQ® (Cabozantinib) Receives Positive Opinion From European Commission (EC) For Medicinal Products For Human Use For Progressive, Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma


12/20/2013 9:58:56 AM

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion of the Marketing Authorization Application (MAA) for COMETRIQ® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). The proposed indication also states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

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