EU approves Cometriq for Thyroid Cancer - SOBI + Exelixis
Swedish Orphan Biovitrum AB's and Exelixis, Inc. announced that the European Commission has approved Cometriq (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary Thyroid Carcinoma (MTC). The European Commission granted conditional marketing authorisation following a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) issued in December 2013. Similar to another drug approved in this setting, the approved indication 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 FDA approved Cometriq for the treatment of progressive, metastatic MTC in the United States on November 29, 2012.
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